Alli Diet Pills, Alli FDA Approved Weight Loss Drug

Side effects of Alli, cost worth considering

2007-08-22T11:09:00.000-07:00

Two years after giving birth to a healthy baby, Jessica Davis decided it was time to lose those last stubborn "baby weight pounds."

She had tried other diets, but 15 extra pounds refused to budge. After learning of Alli (pronounced "ally"), the first FDA-approved diet pill cleared for over-the-counter sales, she decided it was time for something new.

"I really didn't have a lot of weight to lose, maybe 10-15 pounds to get me back to my pre-pregnancy weight," said the 25-year-old Mendenhall resident. "After hearing about Alli, I decided to see if this would jump start my weight loss."

Manufactured by GlaxoSmith Kline, Alli is a less potent form of the prescription drug orlistat. The drug previously was marketed in 1999 in prescription form by Roche Holding AG under the brand name Xenical, which had limited success on the market.

GlaxoSmithKline's expectations for Alli are much higher than those for Xenical. The company is spending millions marketing the drug in television, radio and print ads and expects to net at least $1.5 billion in annual sales.

While the impressive media hype has created strong consumer interest, physicians, pharmacists and dietitians are balancing the marketing spin with some words of caution. Most notably, health officials argue the drug's high cost and limited effectiveness may not be worth its unpleasant side effects.

Brandi Reed, pharmacist at Target's I-55 North store in Jackson, said Alli works by blocking enzymes that digest fat, which prevents the body from absorbing about one-fourth of the amount of fat that is eaten. The undigested fat is then excreted from the body, creating side effects that can include diarrhea and uncontrollable bowel movements.

"Studies have shown that those who combined the use of Alli Diet Pills with diet and exercise only lost about three pounds more than people who only dieted and exercised. That is not a lot of weight when you consider the side effects and the relatively high cost of the drug."

Dosage instructions warn that to be effective, Alli must be taken three times a day. The pills are projected to cost $1 to $2 per day, with no insurance coverage since they are over-the-counter medications. Reed said 120 capsules cost $72.99. There's also the option of purchasing 60 capsules for $49.99 or 90 for $59.99.

Reed said another serious side effect of Alli besides gastrointestinal upset is interference with the body's absorption of some vitamins. Anyone who takes Alli also should take a daily multi-vitamin, Reed said. Customers who ask her about the drug's side effects also get additional advice.

"The company states that some of the more unpleasant side effects may be lessened if you stick to a diet containing 15 grams of fat or less," said Reed. "If you follow a low-fat diet along with exercise, chances are you will lose weight and not need the pill in the first place."

University of Mississippi Medical Center dietitian Jana Milam urged those considering the use of Alli to understand that the new drug is not a "magic bullet." Milam said the success of Alli or any other diet pill is contingent on implementation of a healthy lifestyle that includes a well-balanced diet and exercise.

"Despite some of the reports and sensational headlines, the road to permanent and long-lasting weight loss is not through a pill or any specific 'magic' diet," said Milam, who counsels UMC patients with diabetes and weight issues. "A low-fat diet and regular exercise is the only real way to lose weight and keep it off."

Leaders of UMC's Weight Management Clinic like Dr. Annette Low and clinical psychologist Karen Grothy urge patients to follow Milam's advice to diet the regular way. The clinic promotes a three-pronged approach in its doctor-supervised program that includes proper nutrition, behavioral changes and exercise.

"Any time a drug like this goes over the counter, it gives false hope to those who think there is a quick fix to weight loss," Grothy said. "This is not an unsafe drug, but it does not come without serious side effects. It is definitely not the miracle cure for weight loss."

Although Alli may be helpful for a small number with no history of weight problems, the drug's advertisements may be misleading for those who don't "read the fine print," Grothy said.

"Alli may prove effective for certain people if they include life-style changes into their daily lives," she said. "What consumers fail to realize is that taking a diet pill will not lead to permanent weight loss. Unless someone undergoes a complete lifestyle makeover that includes implementing proper dietary and exercise habits, the weight loss is temporary and will come right back once the pills are all gone."

Grothy and Milam agreed someone taking Alli initially could lose weight because the body will not absorb all of the fat that is eaten. This may cause the person to stop taking the drug after an optimal weight is achieved. Because dietary changes were not made, the body will soon absorb the fat that Alli helped reject, causing weight to return to its previous level.

"If there was a pill that caused everyone to lose weight in a sensible manner, we wouldn't need any other weight-loss programs," Grothy said. "Unless you look at weight loss as a slow process that must include a proper diet, regular exercise and lifestyle changes, you are not going to achieve the results that you want."

As for Davis, she has lost seven pounds in three weeks and is pleased. Side effects have been minimal, she believes because she followed the company's recommended diet plan and has kept fat intake to a minimum.

"I wouldn't say that Alli is for everyone, but it has given me the help that I needed to lose weight," Davis said. "I think it can be a successful method if you follow all of the directions and realize that there might be some side effects Alli if you don't. And keep your expectations on a realistic level. I think that's the key to any weight-loss plan."

Berger Unveils 'New' Weight-Loss Alternative to Alli and Other Drug Treatments

2007-08-15T11:14:00.000-07:00

More than 17 million Americans are currently using a weight loss supplement or diet pill for the purpose of losing weight. And now, there is a new wonder weight loss drug -- Alli. But there is a better way to lose weight, according to lifestyle expert David Berger. After years of exhaustive research and training, Berger has developed a drug-free way to shed pounds--he calls it "Exercise".

"Our research has shown that people using Exercise several times per week will experience significant weight reduction," Berger says. "There are Alli side effects, however--nearly every person who has tried Exercise has experienced enhanced health and fitness, increased feelings of self confidence and improved energy."

Berger says that Exercise is even more effective when combined with his revolutionary diet plan, "don't eat too much and avoid high-fat foods."

Exercise is available today over-the-counter and comes in many different forms, including sit-ups, push-ups, squats, and walking.

To help as many people as possible take advantage of this break-through in weight-loss technology, Berger has developed the Number One Me personal fitness system, which includes online videos and downloadable Exercasts. Visit www.numberoneme.com for more information.

About David Berger -At the age of 18, weighing over 250-pounds with a 40-inch waist and smoking a pack of cigarettes a day, David Berger struggled to climb a single flight of stairs. David's journey to better health began when he quit smoking. He also decided that he would immediately begin eating healthier and exercising, climbing a single flight of stairs a day and adding another flight each week. He also started performing callisthenic exercises. Through his commitment to his consistent and progressive approach, he lost over 88-pounds and 6-inches from his waist within one year. David went on to earn a degree in Kinesiology from West Chester University and launch Progressive Fitness Coaching and now the Number One Me. personal coaching DVD. David and his unique exercise system were recently featured on NBC 10's 10! Show!

About NumberOneMe™ www.numberoneme.com - Increase your core, strength, balance, endurance and flexibility... be fit for life. David Berger's Number One Me - Personal Coaching for Personal Best. Learn to effectively use the single greatest piece of exercise equipment ever created... your body. Over 45-calisthenics exercises instructed for you in three levels of progression; beginner-intermediate-advanced. Exercise at your convenience and in the comfort of your home with peak performance coach David Berger. No more excuses.

Eating disorders patients are likely to abuse Alli

2007-07-22T09:45:00.000-07:00

Eating disorders patients are likely to abuse Alli, the first over-the-counter diet drug approved by the FDA, predicts a Saint Louis Behavioral Medicine Institute psychologist who specializes in treating these patients.

"Because it's been approved by the FDA, people think it's safe. But if patients are already at a healthy weight and are using Alli as part of their eating disorder, then it is not safe.

It can make an eating disorder even worse because it magnifies symptoms these patients already have," says Randall Flanery, Ph.D., who also is an adjunct associate professor at Saint Louis University School of Medicine.

One of the main side effects of Alli is diarrhea.

"For someone who has been abusing laxatives, diarrhea is no big deal.

What might be a more discouraging side effect for a healthier individual becomes an attraction for someone who has a serious eating disorder."

Not a miracle drug, but alli has its place

2007-07-20T10:58:00.001-07:00

Alli is another soldier in the battle against obesity. When this compound was available under the name Xenical (orlistat), prospective users had to get a prescription for it. In theory, this would have included a talk with your physician about potential side effects. Now, with alli, you have a version of orlistat that is available over the counter. As an OTC product, alli was tested for safety and efficacy before being released on the market. This being said, there is an increased level of self-reliance when a product can be purchased and used at will.

Xenical and alli work by inhibiting the action of lipase, a key fat-digesting enzyme that breaks apart the fat in the food we eat prior to absorption. When lipase is unable to work, these fats remain in your gastrointestinal track and are eventually eliminated. The dose determines the effect. With Xenical, approximately one-third of the fat consumed is not absorbed. With the OTC version, alli, only one-quarter of dietary fat is affected.

I am not a big fan of such drugs, but I recognize that they might be appropriate when morbid obesity (weighing more than 100 pounds over your recommended weight) interferes with normal activity and physiological functions, such as difficulty in breathing when one lies down, or when the obesity is directly related to diseases, such as hypertension or diabetes. I have some concern for people who might turn to alli as a quick-fix way to drop a few pounds. The main reason for my concern has to do with the adverse effects caused by the undigested fat passing through the intestines.

According to Xenical's Web site, these effects include "gas with oily discharge, an increased number of bowel movements, an urgent need to have them, and an inability to control them, particularly after meals containing higher amounts of fat than are recommended." This comes from the company selling the product. Because fat is the provocateur, eating a low-fat diet minimizes the side effects. There will definitely be a punishment factor for anyone who might consider such a drug as a license to eat more fat.

For anyone considering alli or orlistat, I encourage you to read all the information before you start. Once you purchase an alli starter pack, you can access a free online counseling service at http://www.myalli.com and receive a personalized action plan and answers to your questions.

Safety of new weight-loss drug is questioned

2007-07-20T10:56:00.000-07:00

A new over-the-counter weight-loss drug called Alli may give people with eating disorders another tool to harm themselves, local therapists fear.

Alli — pronounced "AL-eye" — is the only weight-loss medicine on the market approved by the federal Food and Drug Administration. It's half the dose of the prescription drug orlistat, trade name Xenical, which is used to fight morbid obesity.

Dr. Randall Flanery, head of the Eating Disorders Program for the St. Louis Behavioral Medicine Institute, says the new drug is ripe for abuse because young people with eating disorders find the side effects of intense diarrhea and other gastrointestinal problems that empty the digestive system inviting.

People who use diet products to bolster their eating disorders "… tend to take them at much higher dosages than recommended, as much as 10 times," Flanery says. "It's analogous to laxatives. People with eating disorders take 10 to 50 (laxative pills) at a time. They become dependent and take higher and higher dosages."

Another danger is that the medicine is approved by the FDA "… and people will believe that because it's over-the-counter and FDA-approved, it must be safe," Flanery says. "It's not."

The drug should be kept behind counters and monitored for distribution to make sure that at least teens don't have access to it, Flanery says.

What is it?
The FDA approved Xenical nearly 10 years ago. It limits the absorption of fat so that the fat doesn't enter the bloodstream as triglycerides. Triglycerides are used for fuel and are stored in fat cells. In excess, they clog the blood vessels and help cause heart attack, stroke and organ failure. They can elevate because you eat too much fat or because you have a disease such as diabetes.

The FDA approved Alli in February at 60 milligrams. (Prescription-strength Xenical is sold in 120 mg capsules.) The manufacturer, GlaxoSmithKline, says in its advertising literature that the drug can increase weight loss by 50 percent if it's used along with a reduction of fat intake and an increase in exercise.

But you can experience oily diarrhea, flatulence and other intestinal side effects.

Not unanimous
A weight-loss specialist says anything Alli can do can be done for a tiny fraction of the cost by medications that are easier to purchase by minors.

"There are a lot of cheaper ways to get diarrhea," says Dr. Samuel Klein, head of the Weight Management Program at Washington University. "This medication is $60. …" That's for 90 pills.

"It's half the dosage (of the prescription version), and the manufacturer is marketing it responsibly as something that needs a change in lifestyle to work," Klein says.

Also, he says, the gastrointestinal problems are bothersome enough that even someone with an eating disorder wouldn't want to face them, especially with easier alternatives.

Eating disorders
Flanery's concern is that people with anorexia nervosa and bulimia — about 1 percent of the female population under 24 and a growing number of men — use a bunch of tricks to get thinner.

The tricks include faking eating, taking laxatives, purging (vomiting a meal), isolating themselves and taking amphetamines to reduce appetites.

Debbi Kuehnel, a counselor and owner of the Eating Disorder Recovery Center, wants the drug to be taken off the market. People with eating disorders are as prone to trends as anyone, and Alli's newness could be its attraction, she says.

"We already had a client who stole a bottle," Kuehnel says. "She took 10 pills. They don't care about the side effects.

"Putting this drug on the market was ridiculous," she says. "The ads say eat right, exercise and change your lifestyle and use the drug. You'll lose weight if you eat right, exercise and change your lifestyle; you don't need the drug. The prescription dose was meant for people who are morbidly obese; there's no need to make it over-the-counter."

Local response
The four largest chain pharmacies in the area restrict the sale of Alli by locking it in cases, selling it from behind pharmacy counters and by not selling it to anyone under 18. But spot checks throughout the area found the measures inconsistent from store to store within the same chains.

Alli: Miracle drug or just a pain in the butt?

2007-07-18T10:50:00.000-07:00

The first over-the-counter weight loss drug hit store shelves this summer to mixed reviews.

Alli keeps the body from absorbing fat, but critics say the possible alli side effects are too disturbing to make it worth it. Do users agree?

Drug maker, Glaxosmithkline, doesn't beat around the bush. On its website, it warns you that it's probably a smart idea to wear dark pants and bring a change of clothes to work if you just started taking Alli because there's a possibility you may have a very unpleasant accident.

Still, there is no shortage of people who will risk public embarrassment to shed a few pounds. They each have their own stories to tell.

Trisha Montgomery has yet to master the art of losing weight, but there was a time when she thought she had. Three-years-ago, her doctor prescribed her the prescription drug Xenical to help her prevent acid reflux.

Soon, this Dale, Indiana mom says she went from 206 pounds down to 189, "It did work. I mean, I lost the 17 pounds in like three months, so that was pretty cool."

What wasn't so cool was what she had to go through to get there.

The list of side effects is as long as it is revolting: spotting, gas, increased bowel movements, uncontrollable need to use bathroom; abdominal pain.

But what you won't see here are jitteriness, dry mouth and sleeplessness, the things we commonly associate with taking diet pills. That's because the drug doesn't work on the heart or brain, only the digestive system.

That's one of the reasons the FDA allowed Xenical to be sold over the counter at half the dose under the brand name Alli.

Alli blocks the absorption of about 25% of the fat eaten, so users are encouraged to have no more than 15 grams per meal. Otherwise, they'll pass the extra fat and risk those nasty side effects.

Trisha says she thought she was safe eating only Lean Cuisines, but, "When I started eating those diet things at the store, I was like, 'I thought this was supposed to be low in fat?' yeah, uh-huh, there is something funny about that."

Trisha says she wasn't laughing when she was running to the bathroom, "After a few embarrassing moments, you figure it out pretty quick."

Keep in mind, you're still going to have to diet and exercise. The pill doesn't work alone. Just ask John Finley of Henderson. Between his work as a salesman and his newborn son, he says he isn't working out as much as he'd like, "That's what I was looking for in the pill to do that extra...to be in place of changing my diet. My diet is kind of set and strange."

Every single night, John eats a large frozen pizza and an entire half gallon of ice cream.

Amazingly, John says he isn't paying the price for his high fat, highly unusual meal plan, "I'm happy that I'm not having the negative effects that come with it, but I'd like to know that something was going on."

He has yet to lose a single pound, but he says he is not giving up on the idea of the magic bullet, "There are scientists out there who are trying to figure this stuff out. I guess I'm a little naive, or trusting or want to believe. One of these days, they're going to figure it out and if I don't take it, everybody's going to be skinny but me."

For Trisha, that day is already here. She believes Xenical was the answer to her prayers and can't wait to start taking Alli.

She has this advice for others considering taking it, "Just watch what you eat because of them embarrassing moments!"

So for Trisha, the results are manageable. She said once she figured out that she couldn't eat her favorite Three Musketeers candy bars, she was good to go.

Once she stopped taking the medicine because she couldn't afford it anymore, she says there was no incentive not to cheat on her diet and she gained back the weight and then some.

She was paying about a $168 dollars a month when the drug was Xenical.

The over the counter version is pretty pricey too, at around $50 bucks.

http://www.14wfie.com/Global/story.asp?S=6802161&nav=3w6r

People Are Stealing Alli, The OTC Weight Loss Drug

2007-07-17T11:05:00.000-07:00

Walmart blog "Behind the Counter" has some interesting anecdotal evidence to present to the internet: People are stealing the new weight-loss drug, Alli, like crazy. BTC wants his Walmart to lock up the drug, but they refuse...claiming that they'll lose sales if people can only buy it during pharmacy hours.

BTC says that the starter packs cost $68 at Walmart and, "Every day we find about 4 of them ripped open and the pills stolen."

That's too bad, because we're sure the box that the thieves left behind contains a warning about how Alli makes you crap your pants. We hope the Alli thieves never make it on to COPS. We just don't want to see that. Uh, not that we watch COPS or anything.

Alli’s oily discharges & prepaid healthy food cards for students

2007-07-15T10:54:00.000-07:00

One senses an emerging trend in weight-control and -reduction regimens. This trend can be summed up in one simple word: coercion. Or, to elaborate: achieving dietary goals by confronting dieters with the choice of (1) eating fewer unhealthy foods or (2) experiencing painful consequences. This trend can be observed in two subjects that have been cropping up in the news lately.

The first subject is Alli, the hot weight-loss drug of the moment, which technically works by preventing about one-quarter of the dieter’s fat intake from being absorbed by the intestines. So far, it seems that the results have been largely positive. But the key to Alli’s effectiveness is not that it passes fat through the body harmlessly, but that it often passes through it awkwardly and unpleasantly, in the form of abrupt outbreaks of noxious gas, oily discharge, and the need to hit the nearest restroom pronto.
Wear Your Track Shoes When You Use Alli

As one Alli user told a writer for USA Today, the drug works because “it keeps you on the straight and narrow, because you don’t want any adverse reaction.” Other users tell of mortifying, or highly inconvenient, dashes to the bathroom caused by just an extra cookie or so. If you’re on Alli, you court such ugly moments if you consume more than 15 to 20 grams of fat per meal. Pack away an McD’s Quarter Pounder with cheese (26 grams), for example, and you’d better be wearing your track shoes.

In short, Alli’s magic is that it forces the dieter to genuinely change his or her eating habits, from fast and junk and snack food to the world of produce and fruit and grains. It seems that nothing quells that urge to take the second slice of pizza than the certainty that you will suffer, and if in public, embarrassingly so.
Kids Subvert Schools Healthier Food with Off-campus Purchases

The other area conducive to the element of coercion might be that of children’s eating habits at school and other places outside the home. The unhappy fact is that time and again, efforts to shift young peoples’ diets from fattening snack and fast foods to healthy alternatives have foundered on the shoals of kids’ taste preferences. Reports of this come from the United States, Canada, and Britain, but one of the latter, found on the Internet, produced an idea with compelling possibilities.

The news item itself dealt with the move in U.K. schools to cut way back on fried and fatty foods in the burger and fries vein, and to replace chips and soda with juice or milk in the vending machines, and the resulting stampede of students away from school cafeterias to off-campus fast food alternatives.

The 30 percent drop in student patronage has put the whole program in dire financial straits. As one official fretted, “We cannot expect to reverse an embedded eating culture overnight nor can we convert teenagers to a healthier regime by force.” Oh really? Says who? In fact, an argument to the contrary was suggested by two comments posted to the item.
Prepaid Food Cards Could Outsmart Junk Food Junkie Students

Comment A: “I believe children ate so much better when there was no choice at school and they either ate what was given to them or they went hungry.” Comment B: “Simple solution. Introduce a smart card the parents can fill up with money to be spent only in the school cafeteria.”

Let’s take the principle of Comment B onto a larger scale. Let’s propose that a Health Credit Card be created, which parents could give to their children in lieu of lunch money or that portion of their allowance alloted for food purchases. The HCC would only work, however, when purchasing food items that qualified for healthy status—low on calories and sugar and fats and the like and high on nutritional value—whether the purchase be made at school, a convenience store, or fast-food franchise.

All other food purchases come out of your own spending cash, kid. It’s either the parent-paid apple juice and bran muffin, or the costly Slurpee and fries whose indulgence will leave less to spend on gaming, downloads, movies, and lip piercings.

http://calorielab.com/news/2007/07/16/force-feeding-allis-oily-discharges-prepaid-healthy-food-cards-for-students/

New weight-loss drug fails to gain among Des Moines dieters

2007-07-09T12:12:00.000-07:00

You've read the statistics about obesity in America - about 33 percent of adults are obese; approximately 17 percent of adolescents are overweight.

Some, frustrated with their efforts to slim down, will turn to a pill to lose the extra pounds. It may be a drug designed to promote weight loss or one where weight loss is a side effect.

One of the new pharmaceutical weapons for the millions battling their weight, a drug called Alli, hit the market late last month.

Alli, a nonprescription version of Xenical, was the first of its kind to be approved by the Food and Drug Administration.

The drug works by preventing fat from being absorbed in the system - a process called malabsorption.

The major drawback with Alli, health care professionals in Des Moines said, is an unpleasant side effect, diarrhea.

Because fat cannot be absorbed, eating something like a cheeseburger will trigger the reaction.

Because of that, health care professionals were skeptical that patients could religiously use the drug.

It is that nasty side effect, coupled with an average cost of $60 a month, that seems to be behind Alli's lackluster sales, said John Forbes, owner of a Medicap Pharmacy in Urbandale.

Forbes initially predicted a rush on the drug. "It was a lot less than we anticipated. I was a little surprised," he said.

For those seeking to lose weight, another pharmaceutical option, while less widespread, has been to prescribe medications that have a side effect of weight loss.

This includes certain antidepressants, professionals in Iowa said.

While drugs can produce short-term results, they added, lifestyle modifications including exercise and a healthy diet are needed for long-term weight loss and maintenance.

Sometimes, doctors will prescribe drugs - the most common ones being antidepressants like Prozac and Wellbutrin - to help patients lose weight, Forbes said.

Most times, general practitioners are writing the prescriptions.

"We don't see a great deal of it, though," he said. "It's not the norm."

Physicians can legally prescribe a drug for an "off-label" use, which means the medication is being used in a way for which it was not originally intended.

Patients may be prescribed, for example, higher than typical doses of Prozac, Forbes said. But with that comes more side effects, which include sleeplessness, nervousness and some tremor.

"In our experience, I haven't seen people on that type of medication stay on it long term because of the side effect profile," he said.

"I'm not a big proponent of diet pills myself, because I think it's more of a lifestyle change. You can deal with the medication in the short-term ... and exercise and diet is what really makes the change."

Forbes said other drugs that can cause weight loss include Topamax, used to treat migraines and seizures; Strattera, a treatment for ADHD; and Metformin, a diabetes drug.

Dr. Steve Richards, a family physician in Algona, said in the nearly 30 years he's been a physician that he's only once prescribed an off-label use for a drug for weight loss.

Richards said it's not a typical practice for doctors to write such prescriptions. "I don't think it's going on much at all."

Richards prescribed Wellbutrin to an overweight teenager, who lost about 25 pounds.

"I don't think there's anything wrong with doctors using an off-label use of a drug like Wellbutrin, as long as the person has no contraindications to it," said Richards, immediate past president of the Iowa Medical Society. He added that it should be used in conjunction with diet and exercise.

Dr. Michael Sutcliffe said he's treated several patients suffering from migraines with Topamax who have lost a significant amount of weight on the drug.

"It's just a nice side effect for the patients," said Sutcliffe, medical director of the Mercy Center for Weight Reduction's Optifast and Optitrim Program.

Sutcliffe prefers to prescribe the longtime weight loss drug phentermine, an appetite suppressant. "Phentermine is safe and it works," he said.

But he said the best treatment for weight loss is frequent meals - about six or seven meals of 150 to 200 calories each daily - and increased physical activity.

Src: http://desmoinesregister.com/apps/pbcs.dll/article?AID=/20070708/LIFE02/707080304/1031/BUSINESS02

Diet pill’s icky side effects keep users honest

2007-07-08T10:52:00.000-07:00

Sometimes, you can’t stop your weight-loss secrets from leaking out.

Dieters have been flocking to drugstores to pick up Alli, the first over-the-counter weight-loss pill to be approved by the Food and Drug Administration, despite the scary warning: Stray too far from your low-fat diet and you just might poop your pants.

The drug’s maker, GlaxoSmithKline, has been up front about the pill’s side effects, suggesting that first timers wear dark pants or bring a change of clothes to work until they get used to the diet pill’s potentially yucky consequences.

Still, it seems there’s no shortage of people willing to risk public humiliation to shed a few pounds. At one Los Angeles-area Walgreens, pharmacist Susie Uyu’s seen customer after customer march directly through the store toward the prominent Alli display. “I think they’re excited that it’s an over-the-counter product,” Uyu says.

And even though pharmacist Miyuki Anderson, who works at a Bartell Drugs in Seattle, warns everyone who eyes the Alli display about the messy side effects, it doesn’t stop most of them from buying the diet pill. (Anderson does, however, arm them with this helpful tip: “I tell the patients, try when you have a day off.”)

“We know it’s selling very well — better than we expected,” says Brian Jones, a GlaxoSmithKline spokesman. Jones declined to share any specific numbers. “But we don’t know if it’s going to last — there was a lot of pent-up anticipation.”

Anyone can try it
That anticipation refers to the origin of Alli; it’s the newly approved over-the-counter form of the prescription weight-loss drug Xenical. Now that it’s available in many major drugstores and grocery chains, it’s not just for the obese with a doctor’s prescription in hand — anyone who wants to lose a few can try it.

“The pill offers the promise of convenience, that someone has done the job for you,” says Adam Drewnowski, director of the Center for Public Health Nutrition at the University of Washington in Seattle. “People who don't live well, who stuff themselves with bags of snacks, in desperation they reach out for a pill.”

The drugmaker states very clearly that it’s no miracle drug, and only promises to help people toward moderate weight loss. For example, if someone were to lose 10 pounds from dieting, they’d lose 15 by combining their diet with Alli.

The diet pill works by blocking 25 percent of fat from being digested. Alli users take one pill with every meal, and to avoid an “Alli oops,” they should eat less than 42 grams of fat a day, or about 15 grams per meal. But those fat grams can be sneaky. One grande Starbucks Caramel Frappuccino contains 15 grams of fat, and if an Alli user adds even a low-fat muffin to that meal, it could get icky.

“It’s so important to understand that you must adopt a low-fat, healthy lifestyle,” Jones says. “We call them treatment effects — that’s a signal for you that you’re not staying in the guidelines. What Alli will not do is make up for not living a healthy lifestyle.”

Cheaters share cautionary tales
But we don’t always like to bother with directions. Those who haven’t completely followed instructions offer cautionary tales on the drug company’s Web site.

“(I)’ve pooped my pants 3 times today, and sorry to get descriptive but it even leaked onto the couch at one point!” writes one user.

It can strike any time — even in the early hours of the morning. One user writes: “(Y)a know how when you start moving around in the morning ya pass a little gas. Well, I did and then went into the bathroom and to my horror I had an orange river of grease running down my leg.”

Fellow cheaters advise each other on the best clean-up methods, and some even suggest using panty liners or Depends. One frugal user noted, “I’m thinking that infant diapers might be a cheaper way to go, just use them as a large pad.”

The gross side effects might scare away the less-committed, but some experts appreciate Alli’s very real, very immediate consequences of cheating on your diet.

“It forces you to eat a lower-fat diet — if you don’t, you’re violently penalized for not doing so,” says David Sarwer, the director of clinical services at the Center for Weight Loss and Eating Disorders at the University of Pennsylvania School of Medicine. “When they eat a little too much fat, they’ll learn not to do it again.”

The drugmaker claims Alli is promoting healthier lifestyles by teaching users that weight loss involves eating healthy food and getting enough exercise — and Sarwer agrees.

“People who are struggling with their weight assume that thin people never think about what they eat,” Sarwer says. “I’ve always been impressed by patients who really rolled with the punches with some of these events. They say, ‘Well, I learned that I couldn’t do that. It taught me to eat differently.’ And that’s where I think Alli can be the greatest benefit.”

Side effects are avoidable
Some Alli enthusiasts have been conscientious enough to avoid any side effects. Carole McMahan, who’s trying to lose 10 pounds, started taking Alli the day the product hit drugstore shelves on June 15, and has been careful to follow the low-fat diet.

“No pun intended, but I’m very anal about it,” says McMahan, who’s 44 and lives in Greensboro, N.C. She appreciates the way Alli holds her accountable to her eating habits.

“I started very cautiously, and I’ve just grown more and more comfortable with it,” McMahan says. “I just follow the diet. I knew I couldn’t go out and order hot fudge cake.”

But some Alli fans, like 25-year-old Rachelle Beaini, are just asking for it. Beaini, who lives in Henderson, Nev., and wants to lose 20 pounds, has lost 6 pounds in two weeks without a single side effect. Inspired by her success, last week she dared to eat a meal of chicken nuggets — while wearing white pants. (Still no unpleasant consequences, she swears.)

Still, as some obesity experts point out, if you’ve made a change in your eating habits, why is a diet pill necessary? Drewnowski, the Seattle public-health researcher, says that hearing “Alli oops” stories frustrates him.

http://www.msnbc.msn.com/id/19587389/

Downsides of diet pill Alli include high price, possible side effects

2007-07-06T08:42:00.000-07:00

Paula Hadwin dropped 30 pounds cutting carbohydrates and using the Atkins diet.

"But then I hit a plateau," said the Minden resident, who still wanted to lose 10 more pounds when Alli, the first over-the-counter Food and Drug Administration-approved diet aid, hit shelves June 15. "I decided to try it."

Alli (pronounced "ally"), sold by GlaxoSmithKline, is a half-dose of the drug Orlistat, which has been marketed in prescription form by Roche Holding AG under the brand Xenical since 1999.

Alli aids in weight loss by preventing the body from absorbing part of the fat you ingest. The claim being you lose almost 50 percent more weight than you would without it.

"We've had a lot of people asking about the product, but I wouldn't say it's flying off the shelf," said Youree Drive Kroger Store manager John McNeil.

Downsides to the product are the price — a 30-day supply (90 pills) costs about $60 — and possible side effects of alli. The product comes with several warnings on what to expect, including the caution to wear dark pants and bring a change of clothes with you to work until you have a sense of any treatment effects.

"If you're not absorbing fat and you're still eating fat, it will go in the stool," said Dr. Anthony Stuart, an internal medicine physician and the weight and wellness director for Willis-Knighton Health System. "Some patients will experience gas, frequent and possibly urgent and unpleasant GI (gastrointestinal) side effects. In that respect, it also acts as a deterrent to eating fat."

The product recommends a multivitamin to offset a potential deficiency.

Side effects and all, Stuart supports the product as long as it's used as a tool.

"It's been well studied. And a third of the adults in the country are obese, not just overweight. If it gets people thinking about weight, then that's a good thing," said Stuart, who doesn't recommend any of the plethora of food supplements on shelves that claim weight-loss magic. "Those products are food supplements and haven't been studied. Ephedra is an example. That had problems and they took it off the market."

There are very few FDA-approved diet aids for long-term weight loss; Meridia an appetite suppressant being the only other one besides Orlistat, both of which are recommended only for people who are obese (having a body mass index of at least 30.)

"Even mild or moderately overweight individuals can take Alli," Stuart said. "But at the end of the day, if you are trying to lose weight, you need to do things that are part of a lifestyle change and then maintain those changes. This is just a boost."

Hadwin, 55, has been a perfect example of how the product should be used.

For a few days before she bought it, she did a little research to ensure it would fit her needs. Then with store specials and coupons, she got the product for $32 and has a second coupon to use if she decides to buy it again.

"I've lost three pounds and I've had none of the side effects," said the retired teacher who's been careful to follow the recommended low-fat diet. "The product comes with a lot of good information on a low-fat diet and comes with a journal."

The Web site MyAlli.com provides customers with even more information, tips and motivational tools to use once they register their product on the site.

"I got an e-mail in the middle of the week with information about internal and external hunger pains," said Hadwin, whose not expecting at this point to need another 30-day supply. "I'm going to try and maintain the low-fat diet even when I'm through and I've tried to stay more active.

"For me, it's going to serve my purpose."
Src: http://www.shreveporttimes.com/apps/pbcs.dll/article?AID=/20070701/NEWS01/707010332/1002/NEWS

Diet drug brings foul side effects

2007-07-05T08:31:00.000-07:00

Despite its name, the highly hyped weight-loss drug Alli may not be your friend.

Friends don't put friends in embarrassing situations.

Alli, whose pharmaceutical name is Orlistat, is a 50 percent reduced-strength version of the prescription drug Xenical. The drug's primary function is to prevent the absorption of fats from the diet, which results in losing weight, said Dr. Jan McBarron, a Columbus physician whose speciality is weight control.

The drug, however, has unpleasant -- potentially humiliating -- side effects. They include "gas, incontinence and oily spotting. These side effects are obviously quite uncomfortable and inconvenient at times, and have caused some individuals to think twice about taking this drug," according to www.skinny-

ondiets.com.

"Everybody is asking questions about it, but we haven't had too many people get it," said Sumner Kelly, a pharmacist at Dinglewood Pharmacy. "They ask about the side effects, and they don't want to buy it because of the side effects."

Those who take the drug will soil their clothes, McBarron said. According to Alli's maker, GlaxoSmithKline, the side effect can be seen as a behavior-modification tool.

"It's called rectal leakage -- and it's really uncontrollable. It's 'you need a diaper' controllable," McBarron said. "And it happens in everybody. Not just some people. It is a consequence of taking the drug."

Possible dangers

Leakage may be embarrassing, but the drug also poses some danger. The real danger is that, in addition to blocking some of the fat you are eating, it also blocks the fat-soluble vitamins in the body, some of which are antioxidant vitamins that are necessary for vision and slowing down the aging process. Antioxidants are also necessary for those who are hypertensive or diabetic, McBarron said.

"In the very age population that needs these nutrients, you are giving them something that will take them away," McBarron said. "And that's really the danger of it."

When a person dies of starvation, that person doesn't die because the body didn't get any calories -- he or she dies because the body received no nutrition, she said.

McBarron said people who decide they want to take the drug should understand that Orlistat is not an appetite suppressant.

"You are going to be as hungry as you always are. And you really have to limit your fat intake," she said. "The drug is often misused because people know it is a fat blocker, and they think they can chow down on burgers and fries and onion rings and the fat blocker will block some of the fat.

"The more fat in your diet, the worse the side effects are," she said. "So you have to be on a low-fat diet if you're going to do this. The perception is, 'This is a fat blocker so I can eat as much fat as I used to and it will block some of it, and I will be fine.' "

That is not the case. The more fat a person eats, the more leakage he or she will experience, McBarron said.

Mechanism

The drug works by inhibiting an enzyme in the pancreas that is responsible for breaking down triglycerides in the intestine. Without the enzyme, fats are prevented from becoming absorbable and may then be excreted undigested. It is estimated that the drug blocks approximately 25 percent of all fat in the diet, roughly 150 to 200 calories per meal, according to skinnyondiets.com.

McBarron said she never thought the drug was very effective. According to studies, the average weight loss is 10 pounds a year, she said.

McBarron said she has had patients ask for the drug, but never more than once.

"Never had a refill -- ever. Ever," she said. "People say 'I really want to try it.'... Then they'd get it and they'd never finish the bottle and they'd never ask me for a refill. They'd come back and want something different, but not that again."

The reintroduction of Xenical in a reduced strength -- as Alli -- was simply a way for the drug company to make more money, McBarron said.

Typically when the time runs out on the patent for a medication, other companies duplicate the product. In this case, McBarron said, the pharmaceutical company convinced the FDA to let them cut the dosage in half and sell it over the counter.

"But cutting the dose in half does not mean you get half the side effects," McBarron said. "Not at all."

Src: http://www.ledger-enquirer.com/news/story/76884.html

Concerned about Alli side effects

2007-07-04T10:46:00.000-07:00

How badly do you want to be skinny? Is it worth soiling your underwear?

Those questions will likely confront users of the new Alli, the first over-the-counter diet drug approved by the U.S. Food and Drug Administration.

Alli (pronounced al-EYE) went on sale for the first time late last month -- a stronger prescription form, Xenical, has been available since 1999 -- and its promotional material alone makes for strong medicine: The drug, which helps people lose small amounts of weight, can cause oily discharges, uncontrolled bowel movements, and gas if you eat too much fat.

Its marketing effort makes an impression by telling users to wear dark pants and carry extra clothes in case they soil themselves.

"Well, that sounds attractive, doesn't it?" Jay Leno cracked June 25 on "The Tonight Show." "You lost a couple of pounds, and you're on a date with that special girl. 'Excuse me while I change my pants.'æ"

NBC's Conan O'Brien also spoke up to pooh-pooh Alli, suggesting that "the drug comes in three forms: pills, capsules and chimichangas."

Even the serious Boston-based Prescription Access Litigation Project, which often sues drug companies, got gleeful. It gave the drug's maker, GlaxoSmithKline P.L.C., its 'With Allies Like This, Who Needs Enemas?' Award for Irresponsibly Selling a Formerly Prescription-Only Weight Loss Drug Over-the-Counter.

The drug's backers say that the embarrassment is exaggerated and that the effects can be managed by a low-fat diet.

Only half of all users had "fecal urgency" or related effects in clinical trials, and just 5 percent quit for those reasons, said Vidhu Bansal, director of medical affairs for GlaxoSmithKline's consumer health division.

"They actually served as a positive feedback tool," she said. "It reminded them that they cheated on their diet."

Caroline Apovian, a Boston physician who wrote "The Alli Diet Plan," which shows how to minimize problems by eating low-fat foods, said she did not understand the shame people might feel over losing bowel control. "It's also embarrassing to be obese," said Apovian, who was a paid consultant to GlaxoSmithKline in getting Alli approved for over-the-counter sales. "It's embarrassing to be dead."

GlaxoSmithKline executives are pitching Alli as part of a lifestyle change, which includes a commitment to eat better and exercise more. Users can log in their progress on the drug's Web site -- www.myalli.com -- and interact with other customers or ask questions of a pharmacist, a nutritionist, a chef and a fitness specialist.

The firm, with a U.S. headquarters in Philadelphia, paid $100 million to Xenical's maker, Roche, for the rights to sell Alli over the counter. GlaxoSmithKline is spending an additional $150 million in a marketing campaign that includes a 60-second television ad and print ads appearing this month in most major magazines, read by 33 million people.

Bill Trombetta, professor of pharmaceutical marketing at St. Joseph's University in Philadelphia, said the comedians' attention has an initial upside. "They got your attention. This is on everyone's lips," he said. "You can't buy this kind of publicity."

But will the exposure move people to try it?

Maybe at first, said Kelly Brownell, who directs the Yale Center for Eating and Weight Disorders. But he predicts "sales will tail off fairly quickly."

"The people who will try it won't lose much weight and won't provide very good word-of-mouth," he said.

"Both the benefits and the side effects are overstated," Brownell added. "It's not going to hurt many people, and it's not going to help many people."

Marion Nestle, a nutrition professor at New York University and a frequent critic of the food industry, noted that many users may replace fat calories by eating more carbohydrates. "A lot of Alli takers will do that and wonder why they aren't losing weight," she wrote in an e-mail.

The early results are sketchy.

In the California beach town of Santa Monica, a Los Angeles Times reporter found that Alli bottles were flying off store shelves.

But in Philadelphia, once dubbed the nation's fattest city, Alli's arrival appeared to be less of a sensation.

"We do have it in stock. No one has inquired about it," pharmacist Maria Taylor at Narberth Pharmacy, said last week, echoing several other Philadelphia-area pharmacists. "Maybe it should come with a coupon for Depends," the adult diaper.

Alli contains 60 milligrams of orlistat -- half the amount found in prescription Xenical. The over-the-counter version is taken three times a day with meals and costs from $60 to $67 for a month's supply. A year's worth costs at least $720.

The prescription drug's U.S. sales have been fading, from $135 million in 2002 to $93 million last year.

Despite the fact that obesity rates are surging, an effective drug remains elusive. "Eating is so fundamental for human existence that the body has multiple redundant systems," said Gary D. Foster, who directs Temple University's Center for Obesity Research and Education and was a consultant to GlaxoSmithKline for its Alli Web site. "So if you block one pathway, it's evolutionarily smart to have a backup."

Alli works by blocking the digestive enzyme lipase, which aids in fat absorption. The firm estimates that Alli blocks about 25 percent of the fat that reaches the gut.

But too much fat can cause oily discharges. "You may recognize it as something that looks like the oil on top of a pizza," an Alli brochure says cheerily.

That is what happened to Paula Miguel, 35, of Hopatcong, N.J. She was one of 400 people picked by the drug firm to receive a six-month supply of Alli for free.

She said it was hardest the first week to establish her routine to walk more and eat better.

She felt a strong urge to go after downing some greasy crab cakes at a friend's house. "When I went to the bathroom, it was orangey, like an oil," she said.

But, she said, that happened only once since she began April 18. Overall, she said, she has lost 23 pounds, falling to 170 pounds on her 5-foot-3 frame. "It's not as bad as they say," said Miguel. "I eat better ... I'm more active. For me, it works fine."

The company said users could expect to lose an average of 10 pounds in a year. But that's high, independent experts say. The more potent prescription version helped participants lose an average of 6.3 pounds by the end of a year, according to researchers who analyzed 50 studies for a 2005 article in the Annals of Internal Medicine.

Paul Woolf, chairman of the department of medicine at Crozer-Chester Medical Center in Chester, Pa., was on the FDA advisory committee that in 2006 recommended that Alli be freed from prescription status.

He called Alli "a real niche product" that causes modest weight loss.

"No one is going to abuse it," he said. "They're going to be very unhappy if they do."

http://www.southbendtribune.com/apps/pbcs.dll/article?AID=/20070704/Lives08/707040465/-1/LIVES/CAT=Lives08

The new weight loss pill, Alli, has questionable treatment effects

2007-07-04T08:34:00.000-07:00

For the first time, the Food and Drug Administration approved selling a prescription-only diet aid over the counter. Although Alli has been selling quickly, its "treatment effects" are controversial.

Alli, which went on sale June 15, is half as strong as its prescribed version, Xenical, said Brian Jones, the vice president of communications for GlaxoSmithKline, the manufacturer of Alli, in an e-mail interview.

According to an Alli brochure, the active ingredient, orlistat, prevents digestion of approximately 25 percent of fat consumed. Instead, it is released as "treatment effects," including gas, frequent bowel movements and oily discharge.

Effects are reduced if the fat intake for each meal is around 15 grams and calories remain low.

If Alli is used with diet and exercise, a person can "lose about 50 percent more weight than dieting alone," the brochure says. Weight loss

Sheida Guilak, Cal State Fullerton graduate and pharmacy manager of Target in Fullerton, said Alli just "might give some people a jump start [in their diet]."

Jones defended Alli when asked about its possible abuse and said GlaxoSmithKline has been candid about treatment effects.

"Post-marketing surveillance recorded shows no signal of people with eating disorders finding any appeal in Alli â€¦ If you are not eating, there is no benefit; if you are binge eating, the treatment effects would be undesirable," Jones said.

But what about nasty treatment effects?

Senior Dustin Martinez, a kinesiology major at CSUF said peers in one of his classes take diet pills similar to Alli with warnings about "anal leakage," but they say these alli side effects do not happen to them.

When asked if he would recommend Alli to someone trying to lose weight Martinez said he would.

"Yeah, because if they're serious about a diet and they eat a lot of fast food, they'll learn the hard way. I think it will help them regulate their diet."

src: http://media.www.dailytitan.com/media/storage/paper861/news/2007/07/03/News/Controversial.Weight.Loss.Pill-2920786.shtml

About new Diet Pill: Alli

2007-06-30T10:15:00.001-07:00

Alli diet pill: Reviews!

2007-06-30T10:13:00.001-07:00

Nutritionists weigh in on new weight loss aid, Alli

2007-06-26T09:29:00.000-07:00

Christina Cesario works out five times a week. She says she'd try the new FDA approved diet pill, Alli. "I would definitely be interested in trying it and see if it helps me loose a few more pounds and how it makes me feel,” said Cesario

The makers of Alli claim it can help its users lose 50-percent more weight than dieting alone. An example they use is, if you loose 10 lbs on your own, you'll loose 15 with Alli.

Nutritionist Kelly Waters says, “I'm afraid that they’re gonna say well this pill is great. I'm just going to take this pill and be okay, when really that's not how it is."

Alli creators say the pill works on the digestive system. Officials say the Alli prevents enzymes in the intestines from digesting about a quarter of the fat a person eats. But if you don't stick to the recommended diet plan Alli officials say there could be "treatment effects." “If people take this pill and they continue to eat fried foods, trans fats, that's when they're definitely going to have the gastrointestinal distress. It will not agree with their body," said Waters.

For some that's enough to stay away from the pill.

Eric Patrick says he’ll never use diet pills. "I probably wouldn't use it. No I think that I would just go ahead with the vegetables and fiber,” said Patrick.

Nutritionists say just because the pill is FDA approved, doesn't mean it will perform miracles.

Nutritionists say some of the fat Alli passes out of the body is fat the body needs. Like Vitamin A, D, E and K.

Alli is only for people age 18 and over.

The makers of Alli say most weight loss occurs in the first six months of use.

A starting package costs $60 for 90 capsules at most stores. The refill packages are $70 for 120 capsules.

Side effects not slowing Alli diet-pill boom

2007-06-25T09:45:00.000-07:00

A new over-the-counter weight-loss pill, which has been disappearing quickly from store shelves across Houston since it became available a week ago, is likely to cause undesirable side effects if dieters don't also abide by the low-fat diet that the drugmaker recommends.

That hasn't stopped thousands of people from flocking to pharmacies to buy Alli, the first FDA-approved nonprescription diet drug. For the past week, pharmacy employees have stocked and restocked their shelves with the pills.

"We can't keep up with it," said Hisham Ghali, executive assistant manager of a Walgreens in River Oaks.

The store had sold out of the largest available bottle of Alli on Thursday, but he expected another shipment within a few days.

Alli, pronounced "AL-eye" and manufactured by GlaxoSmithKline, prevents the body from absorbing fat by blocking enzymes in the digestive system. Made using orlistat, which has been available for several years in a higher-dose prescription form called Xenical, Alli blocks about a quarter of the fat eaten during a meal when users pop a pill beforehand. It can be taken up to three times daily.

Users of Alli can lose about 50 percent more weight than they would through dieting alone, according to GlaxoSmithKline. For example, someone who loses 10 pounds through dieting could lose 15 pounds with Alli, the company says.

The drug can cause nasty side effects, however, particularly for dieters whose fat intake per meal is higher than the recommended 15 grams. (A fast-food hamburger can contain 30 grams.) GlaxoSmithKline warns of the potential for "gas with oily spotting, loose stools or more frequent stools that may be hard to control." The company suggests not taking the pill before meals with high fat content.

Users attest to this on Alli's online message board through posts called "accident support group." Some complain of the bowel changes and leaks consistent with GlaxoSmithKline's warnings, while others say they have constipation or cramping. Meanwhile, dieters considering using the drug ask questions such as, "adult diapers mandatory during first week?"

For at least one Alli dieter, the unpleasant side effects are part of the drug's appeal.

"It forces me to diet and exercise to avoid any bad side effects," a dieter who signed in as Sheree wrote on Alli's message boards. "Trust me, on my own I would have already cheated!"

Low-fat diet is crucial

Two local diet specialists said orlistat can be effective, so long as the user is dedicated to a low-fat diet.

"For the person who's committed to eating right and exercising and doing the right things, then staying on Alli will serve them well over time," said Dr. Tom Lux, assistant professor of internal medicine at the University of Texas Medical School at Houston, who has prescribed Xenical for weight-loss patients. "For a person who likes to eat a lot of steak and heavy food and fried food, it's not going to be a good choice."

After a Walgreens in the Memorial area got its first shipment on June 14, buyers bought all 36 packs of 90 pills, at a price of $59.99, that day. The store got a shipment of 60- and 120-pill packs the following day and quickly sold those, too, said store manager Bill Coligan.

"It was a little busy," he said. "Every couple of minutes, we were over here unlocking the case."

'Not a magic pill'

Stores are keeping the product locked because it's so popular, and pricey, that it's a major target for shoplifters who want to sell it on the street. A 60-pill "starter pack" sells for $49.99, while one with 120 pills goes for $69.99.

The drug also is selling well at other local pharmacies, including CVS and Kroger.

Rebecca Reeves, a dietician and assistant professor at Baylor College of Medicine who has conducted research on orlistat, said having the drug available over the counter provides a great opportunity for people looking to lose weight.

"It's not a magic pill," she said. "It will help you along when you are involved in a good, healthy lifestyle."

http://www.chron.com/disp/story.mpl/front/4914080.html

Examining Alli Diet Pills

2007-06-23T09:44:00.000-07:00

Examining Alli

The first FDA approved over the counter diet drug is now on store shelves.

Alli used to be prescribed under the name Xenical

It works by stopping the body from absorbing 25 percent of the fat injected.

If used in combination with a reduced calorie diet and exercise, it can help a person lose and extra 10 pounds over a six month period.

"The ingredients are in safe amounts and it does what it says it going to do. Whereas a lot of the other weight loss medications they have ingredients in there in unknown amounts and it may not do what it says its going to do," said Ashley Simper a dietician.

The pill isn't cheap, one month's supply is about $60.

Experts say in tests, the pill only worked for the overweight, not the obese

Impatient patients expect quick fixes from pills, patches

2007-06-23T09:23:00.000-07:00

As soon as she was diagnosed with high cholesterol, Maritza Cuestas got a prescription for medication from her doctor.

The 50-year-old Palmdale resident took the pills for a while but stopped because they gave her headaches. "I don't like taking pills," Cuestas said. "Doctors give you something to try, but they don't really know if it's something you need."

Cuestas is now drinking celery juice, a tonic that her mother in El Salvador swears will help reduce cholesterol. Cuestas' co-worker, Josie Carrasco of Sylmar, stands by garlic as a remedy for high cholesterol.

But in general, many Americans simply take a pill for high cholesterol and almost any other affliction - something Cuestas and Carrasco find frightening. "It's not that there are too many pills; it's that people abuse them out of ignorance," Cuestas said as the two recently ate lunch in Woodland Hills.

"A lot of people prefer pills instead of eating right, instead of exercising." Some health experts blame America's obsession with instant cures - an overeagerness to be "pilled" and patched - on time constraints in an overworked society impatient to wait for results of lifestyle changes to kick
Advertisement
in.

It's the American way. "If you think about American culture, some people would say, `Why take a pill?' Others will say, `Why not?' Americans have a very can-do attitude, and we're not very patient," said Carol Scott, professor of marketing at UCLA.

In its first week available without a prescription, the new diet pill Alli was reportedly selling briskly despite widely reported side effects such as involuntary bowel movements and other intestinal discomforts.

GlaxoSmithKline, which makes Alli, declined to give overall sales figures so far. "We do know sales were ahead of expectations," said Malesia Dunn, spokeswoman for the company.

In 2002, the last year for which data were available, 45 percent of all Americans were taking at least one prescription drug, according to the federal Centers for Disease Control and Prevention.

Pharmaceutical companies and many doctors praise the promising research to develop drugs that will cure deadly diseases like cancer, or allow people with some mental illnesses to carry on relatively normal lives.

But critics say Americans are becoming too dependent overall - especially on feel-good, lifestyle drugs.

"If you go to a doctor and he or she doesn't suggest a prescription, you feel like you're not getting treatment," said Louis Rubino, the Health Sciences Department director at Cal State Northridge.

"It's wonderful we have the research and new discoveries, but look what we're doing. We're using pills for erections, to elevate our moods, to sleep."

Heavy use of prescription drugs has created its own problems, some doctors say. Rubino pointed to the overuse of antibiotics, which some worried moms seek whenever little Joey sniffles.

"Antibiotics aren't working any longer because there are different strains of illnesses that have become resistant," Rubino said.

The California Medical Association Foundation launched an educational campaign almost 10 years ago to warn against overusing antibiotics. By 2000, foundation officials say, 30 percent of infections in California were resistant.

In Los Angeles' predominantly Latino neighborhoods, prescription drugs tend to be viewed with some suspicion among newcomers, though attitudes begin to change as American values seep into households.

"When I was growing up, my grandmother believed in herbs," said Maria Sierra, 47, whose family has lived in the city of San Fernando for several generations.

"My grandmother didn't have a normal backyard like everyone else," Sierra said. "Her backyard was filled with flowers and herbs for teas. Strangers would show up ... [on] her doorstep to ask for remedies."

Sierra said once, when she was uninsured, her mother gave her a tea to alleviate pain in her kidneys.

"Now that I work [and am insured], now that I'm older, I'll take the pills," she said.

The number of prescriptions dispensed to U.S. patients increased by 4.6 percent in 2006, after a 3.2 percent increase in 2005. The increase was fueled by the Medicare Part D benefit, more use of generic drugs and the introduction of new drugs targeted to specific diseases such as cancer and diabetes, according to IMS Health, a consulting firm.

"This growth was driven by factors that include an aging population and the Medicare prescription drug benefit," an IMS report says.

Who's buying Alli?

2007-06-21T09:18:00.000-07:00

The first FDA-approved diet pill is selling quickly at local stores. It's called Alli, and stores began selling the diet pill on Friday. It's designed to help people lose about one or two pounds a week by blocking the amount of fat the body absorbs. Manufacturers say it can block about 25 percent of the fat you eat.

Many customers are buying it despite its embarrassing side effects. "I'm a sucker for advertising. I'll buy anything," said Alex Franco, also known as "Digitz" on the "J.B. and Sandy Morning Show." He starting taking Alli on Tuesday, but it's not his first time using the drug. Franco used Xenical, the prescription version of Alli, about seven years ago.

"I said, 'I'm going to try it again,'" said Franco. The prescription drug did help him lose some weight, but the down side of the drug was its embarrassing side effects. "I couldn't do anything. I couldn't go to school. Thank God I didn't have a girlfriend at the time. It was a mess. Seriously," said Franco.

The fat that the body does not absorb simply passes through the body. The makers of Alli warn eating a fatty diet can cause stomach discomfort, from frequent bathroom visits to gas.

"Bring a change of clothing with you. Are you serious? You're going to put this in your mouth," said Sandy McIlree, while reading the lists of possible side effects on the box. Despite discouragement from co-workers, Franco is trying Alli.

"I know that's worked for him. He just started and day one, took the pill and didn't eat any foods with fat in them because you don't want the mess," said J.B. Hager.

Workers at Walgreens say Franco isn't the only one buying Alli. The first day it hit the shelves, all 12 starter kits sold out within the first few hours. One Target location is selling about 10 a day.

Retailers say the hefty price of the new diet pill doesn't seem to be deterring customers either. Alli costs about $60 for a month's supply. The manufacturer points out that it works best along with exercise and a low fat diet.

src: http://www.kvue.com/news/local/stories/062007kvuedietpillfolo-cb.21f2a533.html

FDA Approved Over the Counter Diet Drug Alli Flying Off Store

2007-06-21T08:03:00.001-07:00

According to a report from the Wall Street Journal, the new Alli weight loss drug is flying off store shelves. The new Alli drug was just released last week. This new diet drug is the first over the counter diet drug to get FDA approval.
Xenical, as pictured here, has the same weight loss component as Alli.

One Columbus pharmacy sold out of its complete stock of the new drug, and swift sales have been reported all across the United States.

This new diet aid will cost a buyer $50 for a 60-day supply. Or you can have the option to buy a 90-day supply for about $60. Even though this over the counter drug has received FDA approval, they still caution that the drug should be used with a reduced calorie and low fat diet.

According to a Wall Street Journal report, if a person who eats a 2,000 calorie diet and eats about 30 percent fat per day, will lose about 150 calories taking the pill. Based on this information, a person should lose 1,050 calories per week. A pound of fat in the human body is equivalent to 3,500 calories.

As with most prescription drugs, this drug also has possible side effects. It's possible this extra fat coming out of the body, will be removed in an unpleasant way. The maker of the drug say, Alli can "cause gas with oily discharge and frequent loose stools". GlaxoSmithKline, the maker of the drug, recommends that a smart idea would be for a user of the pill to wear dark pants, and take a change of clothes with you where you go. To help avoid these side effects, Glaxo says you should limit your fat gram intake to 15 grams per meal.

According to Wikipedia, Alli is also called Orlistat and Xenical. This drug has been created to help treat obesity. What the drug does, is help prevent a portion of fat absorption into the human body. The drug is supposed to be used with doctor supervision, along with a calorie restricted diet. The way the fat is eliminated is through a bowel movement.

In one year clinical trials using Orlistat, 35.5% to 54.8% of test subjects saw a 5% decrease in overall total body mass. Although not all of the mass lost was necessarily body fat. About 16.4% to 24.8% saw a 10% loss in overall body mass. When the consumption of the drug was halted, a significant number of test subjects gained weight back. They gained back about 35% of the weight they had lost. Alli has about half the dose of Orlistat, and is sold at 60mg per capsule.

People who take Alli can expect the following two things. One in five people will lose 10 percent or more of total body weight, and half of the people who take the drug will lose less than 5 percent of total body weight.

2007-06-21T08:03:00.000-07:00

GSK's Alli safe weight loss OTC pill, does not affect heart or brain

2007-06-17T07:11:00.000-07:00

Alli is the only FDA-approved weight-loss product available to overweight adults, 18 years or older, without a prescription. It combines a clinically-proven product with a comprehensive individualized action plan.

The alli program encourages modest, gradual weight loss, known by experts as the best way to lose weight. alli (60 mg orlistat capsules) is safe and effective when used as directed.

Orlistat (the active ingredient in alli) has been used by millions of people worldwide. Its safety and efficacy are well established.

According to Vidhu Bansal, Pharm.D., director, Medical Affairs, GlaxoSmithKline Consumer Healthcare, “With a raging overweight and obesity epidemic, alli offers consumers a proven, safe option to help them lose weight without a prescription. Unlike the herbal and dietary supplements for weight loss on the market, alli is an FDA-approved over the counter weight loss product.” Bansal adds, “alli works in the gut; it is non-systemic, which means it is not absorbed into the bloodstream. That means alli does not affect the heart or brain or cause sleeplessness, jitters or an increased heart rate.”

GlaxoSmithKline Consumer Healthcare [NYSE: GSK] announced that alli™, the only FDA-approved over-the-counter weight loss product will be on shelves of US pharmacies, grocery stores and mass merchandisers nationwide this week.

Src: http://www.spiritindia.com/health-care-news-articles-10725.html

Alli Weight Loss Pill May Lead To 'Unpleasant Toilet Experience'

2007-06-16T07:27:00.000-07:00

The first FDA approved over the counter weight loss pill is on the market. The pill is supposed to help people lose 50 percent more weight than other diet supplements. But doctors said the new pill has some side effects that can keep you sidelined.

The new pill is called Alli. Taken three times a day with a low-calorie, low-fat diet, doctors said you'll lose weight. But if you eat food high in fat, you'll feel it.

"It's conditioning. It's like if you eat this stuff, you're going to have an unpleasant toilet experience," Dr. Konoy Mandal with Research Medical Center said. "It's not going to sound good, it's not going to look good and you're not going to be very popular in public."

Alli works by preventing fats from being absorbed in your body, but doctors said it can leave you with some very embarrassing bowel movements.

"Buy some extra underwear," Dr. Mandal said. "You're gonna have some events."

Under the drug facts on the back of the package, the manufacturer said gas with oily spotting and loose stools are part of the treatment effects. "Genius marketing," Dr. Mandal said. "Treatment effects...instead of like farting and pooping explosively."

Aside from the side effects, Dr. Mandal said the online support will help people lose weight.

"I think the power of it is going to be in the online community and the meal plan is going to be the power of it and not what Alli would do in and of itself," Dr. Mandal said.

It took Joan Gunter 11 years to lose 47 pounds with Weight Watchers, because Gunter said she didn't try the support groups. "I never stayed for any of the meetings," Gunter said. "I always thought I can do this on my own and I never really changed those habits and those behaviors."

Dr. Mandal said diet and exercise are key to losing weight, with or without Alli or other weight loss programs.

Alli is sold in major drug and grocery stores and it could affect your wallet too. 60 pills will set you back about $45.

http://www.health100.org

SizePro - Penis Enlargement Pills - Most Advanced and most potent male enhancement available.

FDA-Approved Alli Hits The Shelves

2007-06-15T07:14:00.000-07:00

With obesity an epidemic practically worldwide, drug companies have been in a race to find a diet pill that can be sold without a prescription. Glaxo Smith Klein won that race with a new drug called Alli. But, as Carol Pearson reports, it is no magic pill. Alli requires a commitment to a change in eating habits.

Americans alone spend more than a $1 billion a year on weight loss products. Imagine if the tens of millions of people worldwide had easy access to a diet pill.

“The market is so enormous and there are so many overweight people desperate for solutions,” says Professor Kelly Brownell is director of Yale University’s Center for Eating and Weight Disorders.

Alli is a non-prescription version of Xenical, a more potent, prescription-only weight loss drug. Both drugs are brand names for orlistat. They work by blocking fat in the digestive track. The manufacturer admits Alli is not a magic pill, and users need to make a commitment to lifestyle change.

“The typical pattern for people on weight loss drugs is to go into it with a lot of enthusiasm,” says Professor Brownell. “Many people don’t lose as much as they like. They get discouraged and go off the drug.”

Glaxo Smith Klein advises people to use Alli in combination with a low-fat diet and exercise. But there are some side effects. The pill can cause gas, painful stomach cramps and diarrhea.

While the U.S. Food and Drug Administration approved Alli, the FDA’s health advisory panel rejected another weight-loss drug - rimonabant - because studies show it increases the risk of suicidal thoughts in some patients. Rimonabant’s manufacturer suggested that physicians screen patients before they prescribe this drug. Rimonabant is available in Europe under the brand name Acomplia.

Experts say while weight-loss drugs can be helpful, they miss the larger point, which is more emphasis on preventing obesity in the first place.

Alli Diet Pills FAQs....

2007-06-12T10:24:00.000-07:00

Alli Diet Pills Frequently Asked Questions by Foster:

How does Alli work? Alli is a fat blocker. It works by decreasing the amount of dietary fat that is digested. The 60-mg. orlistat capsules are meant to be taken with already low-fat, low-calorie meals, up to three times a day to prevent enzymes in the intestines from breaking down some of the fat calories you take in. If the fat is not broken down, your body cannot absorb it.

Does Alli have side effects? Yes, Alli blocks the absorption of fat, and that fat is passed out of the body in stools, so it can cause some gastrointestinal side effects, including diarrhea and cramping, especially if you eat a large amount of fat at one meal. (In fact, you might want to start Alli while you're at home: The book warns that when you eat too much fat, effects may include loose or more frequent stools that may be hard to control or gas with an oily discharge.) But there is some good news, says Foster: The drug works only in the gastrointestinal tract so it does not cause sleeplessness, jitters or increased heart rate, as some weight-loss drugs do.

How much can I lose with Alli? It depends on your diet and exercise, but with Alli, Foster says, you will lose about 50 percent more than you would without it. That is, for every 10 pounds you would normally lose, Alli will help you lose five more. If you are on a diet to lose 10 pounds in one month without the medicine, you should lose 15 with it.

What can I do to maximize the benefits of Alli? Write down everything you eat, and calculate how many fat grams each meal contains. A low-fat meal should have 15 or fewer fat grams. Most of us vastly underestimate how much we eat.

Where can I learn more about it? On the Web at myalli.com.

How much does Alli cost? The capsules, manufactured by GlaxoSmithKline, cost 60 to 70 cents each or about $2 per day.

NOTE: Alli is only indicated for use in adults 18 and over.

Src: http://www.star-telegram.com/health/story/128223.html

Alli Success Depends On Picking The Right Diet

2007-06-12T07:13:00.000-07:00

With over two-thirds of Americans now overweight, 70 million over fifty pounds and another 70 million over one to forty-nine pounds, it just may take a combined effort of a diet pill and a diet compatible with that pill.

In February 2007, GlaxoSmithKline Pharmaceuticals announced the FDA approval of the weight loss Orlistat in the form of a lesser dosage, 60 mg capsule, sold over-the-counter starting summer 2007. It will cost 60 cents a capsule taken three times a day with each meal. The company recommends it not be used as a true stand-alone weight loss method, but only in combination with exercise and a diet that is reduced fat that contains about 15 grams of fat per meal.

It’s actually a pseudo-diet pill since its main function is to block absorption of 20-30% of the fat one consumes rather than decreasing the urge to eat. The fat passes out of the body is about 150 to 200 calories. Understanding this fact will determine the success of its usage by a dieter and whether the drug will fail being called the first fad diet pill in history.

If past history shows that controversy sells the most amounts of drugs, alli is getting it with pros and cons. On one end, critics restate the diet pill maker’s own admitted side effects found in clinical studies. While advocates of the much awaited pill feel anything that will help is needed as long as it’s free of severe side effects since the overweight problem in America is now an epidemic and out of control.

With alli one can lose 50 percent more weight than with a diet alone. Low fat diets on the market along with alli should give women 2-3 pounds loss per week and 4-5 pounds of weight loss for men, as long as the diet meets the low fat criteria of the new diet pill.

The diet pill has drawn less criticism than most newly released drugs. Nutritional counselors feel the drug will be abused and that more focus should be placed on change in dietary and exercise habits. Others feel that the drug will fall into the hands of teenagers and college students that will abuse the pill for quick fixes or ignore its fat blocker purpose and not adjust the fat content to their diet.

Critics tend to focus on unpleasant side effects of loose stools and flatulence that happens to be the same listed on food packages that contain Olestra or other reduced sugar candies. This should only occur in those not using the diet pill correctly by having too much fat in their intestines that is not getting absorbed and exits the body with the rest of their wastes. The real unknown at this time is many vitamins are fat based and may be blocked, which can be helped by taking a multivitamin daily.

GlaxoSmithKline has not joined forces with any diets on the market today mainly since it appears that many are not low fat. The Atkins Diet is high fat while the South Beach Diet on its own back cover states it’s not low fat or low carb and therefore will not meet the criteria of alli. The company has a website that is steering dieters to do weight-loss profiles and build customized meal plans and provide feedback on their progress.

Dieters have been the route their website is trying to take overweight people and this has failed in history. They are skeptical of special meals or recipes and need a diet that makes it easy to eat at restaurants. In a very busy society, they don’t want to count calories or carbs, or measure food portions.

It will be a shame if GlaxoSmithKline’s product fails since it appears public abuse of the product may be the only cause of it being pulled from the market one day other than dieters not using it along with the proper diet plan. The FDA recently set guidelines with one being that diet pills are ranked based on their ability to keep weight off for one year or more.

The key will be finding a non-fad diet that allows eating normal foods found in grocery stores and restaurants. The diet chosen to take with this new diet pill will also have to take the brunt of the responsibility in keeping the weight off and not allow a dieter to go back to eating wrong foods or in excess. The diet must change bad eating habits and get overweight people away from the addiction to wrong foods at the beginning of the diet. Alli will help do this by acting as a sort of diet police putting in discipline if one cheats on the correct diet that matches the pill’s criteria and might be what’s needed to put in some dieting ethics.

Other controversy, as exists for all drugs on the market today, is whether there is a contribution to colon cancer. A Brazilian study indicated that similar drugs as Xenical and Orlistat in the higher dosage obtained only by prescription could form cancer. The same occurred in the past when the Sweet-n-Low low calorie sweetener was inappropriately accused of causing cancer when later research article found it safe. Compared to mind altering drugs to lose fat, drugs based on physical blockers and not mental ones may be one of the waves of the future that won’t go away anytime soon.

Src: http://www.eontarionow.com/health/2007/06/16/alli-success-depends-on-picking-the-right-diet/

About Weight Loss Drug Alli

2007-06-10T07:21:00.000-07:00

• What it does: The main ingredient, orlistat, blocks absorption of about a quarter of the fat you eat, preventing the body from storing those calories.

• How it works: It's taken three times a day with meals containing some fat. Users should limit fat intake to 15 grams per meal. (A turkey sandwich with mayo and cheese might have 26 grams of fat or more.) You also need to take supplements containing fat-soluble vitamins, such as A, E and K, and beta-carotene daily (preferably at bedtime) because the drug may prevent you from absorbing the nutrients from your food.

• Possible benefit: You could lose up to 50 percent more weight than with diet and exercise alone. For example, you could lose 15 pounds instead of 10.

• Side effects: They include oily bowel movements, gas and bloating, stomach cramps and an urgent need to go to the bathroom. Effects are more intense when high-fat foods are consumed while using the drug.

• Cost: Prices vary depending on the store, but a starter pack with 90 capsules, a reference booklet, guide to an online diet plan and a carrying case for the capsules costs about $65. Capsules are about 60 cents each in refill packs.

SOURCES: National Institutes of Health, myalli.com

It's Official. Diet Pill alli (Low-Dose Xenical) Will Go on Sale on Friday, June 15th

2007-06-09T20:03:00.000-07:00

Diet pill alli (low-dose Xenical) will go on sale in grocery stores and pharmacies around America on Friday June 15th, according to an announcement on GlaxoSmithKline's official alli website.

The terse announcement said "beginning June 15th, alli will be available in all major drug, grocery, and discount/warehouse stores in the weight loss product aisle."

A number of online retailers have been allowing dieters eagerly awaiting the first FDA approved over-the-counter weight-loss drug to "preorder" alli for shipment the day it is officially placed on sale.

A number of readers have been searching for the lowest price for the diet pill, and have reported their results to our sister newsletter, alli Report.

As of the moment, the lowest price still seems to be offered by MyFloridaPharmacy.com, which is offering the alli weight loss aid starter pack with 90 pills for $58.99.

Two other options also are being offered: the alli weight loss aid starter pack with 60 pills for $48.29, the alli refill with 120 pills for $73.29.

With the launch of sales of the non-prescription drug only a week off, observers expect a new flurry of promotional activity in the days immediately ahead.

Alli Bringing A New Revolution

2007-06-09T19:58:00.000-07:00

Weight Los is one of the important issue is being discussed in New York. GlaxoSmithKline is a well-known healthcare production. It is trying to practice the country for alli by having exhibit in New York City.

Most of people hope of the weight loss without any effort. They want a source that will make them slim while eating anything they want. This is not that they are expecting more. Actually today’s lifestyle have change the people mentality. First of all most of don’t have time for heavy work out and exercises. Also people want a satisfactory food after they get back to home from hectic day.

Having a hectic Schedule Plus dieting can lead to person in stress. So to avoid this stress most people go for diet pills. And they expect a lot more from this diet pills. By having this thing in mind GlaxoSmithKline tries to give a wake up call to the people about the all diet drug. As this is the first over-the-counter pill approved by Food drug and administration.

“We are trying to place alli as an honest voice in publicity. People will come to know difference between the all and rest of diet drugs after its usage” said marketing director of GlaxoSmithKline

The Over the counter dosage of alli is 60 mg, It is a dilution of the medicine amount. Orlistat is not a latest weight loss pill; and had been approved by FDA in 1999.

According to GlaxoSmithKline Alli will emerge as star pill with in a few days and spending $150 million on advertising alli in present year.

Diet drug debuting with big bang!!!

2007-06-09T10:23:00.000-07:00

GlaxoSmithKline Consumer Healthcare is spending $150 million to roll out its much-anticipated over-the-counter weight-loss drug, Alli, next week, with a far-reaching campaign that tries to persuade people to alter their diet and exercise regimes in addition to swallowing the non-prescription capsule three times a day.

Alli is the only federally approved weight-loss medication available over-the-counter.

"If you want to lose weight, you have to make changes in the way you eat and your lifestyle," said Steve Burton, vice president of weight control for GSK Consumer Healthcare, which is headquartered in Moon.

To that end, consumers who plop down about $60 for an Alli starter pak will receive 90 capsules -- a one-month supply -- as well as menu planners, calorie guides and information about accessing on-line help to achieve and maintain their weight loss goals.

Alli is scheduled to hit some store shelves as early as Wednesday but GSK officials don't expect full nationwide availability until next Friday. It will be sold in drugstores, supermarket pharmacies and discount chains.

In 2004, GSK paid Switzerland's Roche Holdings Inc. $100 million for the rights to sell its weight-loss drug, orlistat, over the counter and in February received approval to do so from the Food and Drug Administration. Orlistat is sold in prescription form under the name Xenical. The drug helps users lose weight by reducing by about 25 percent the amount of fat the body absorbs.

Because Alli is the only FDA-approved weight loss drug available without a prescription and has an estimated market of 5 million to 6 million customers annually, GSK is treating the launch with an "unprecedented" marketing strategy, said Mr. Burton.

To generate interest in Alli before next week's official launch, GSK has published a paperback book, "Are You Losing It?" written by a physician, a chef and weight management experts. The book retails for $5.99 and will be on sale where Alli is sold. Proceeds will be donated to programs that target childhood obesity. .....

A 30-second TV commercial already has been running on network and cable stations to alert viewers about the product Web site, myalli.com; and a 60-second TV ad will air later this month after the product is available in stores. Though GSK is touting Alli as safe and effective, criticism has surfaced about its side effects and whether teens looking for quick weight-loss methods might abuse the product because they can obtain it without a prescription.

Yesterday, a consumer coalition, Prescription Access Litigation, criticized GSK for making the drug available over the counter because of its side effects, which the group said include diarrhea, oily stools and flatulence.

GSK has acknowledged that Alli can produce what it calls "treatment effects" such as loose or more frequent stools and gas with discharge. The book, "Are You Losing It?" advises users to start using the product when they have time away from the office or perhaps to bring a change of clothes to work. The effects are manageable, said Mr. Burton.

Because Alli works by removing 25 percent of fat from calories consumed, high-fat meals can cause more undigested fat to pass through the body and result in gas and other side effects.

Clinical studies showed about 50 percent of users never experienced such effects, he said. As for concerns about teenagers abusing Alli, Mr. Burton said product labels will state the product is intended for overweight people ages 18 and over.

New Diet Drug Promises To Help You Lose Weight

2007-06-01T20:01:00.000-07:00

A new over-the-counter weight loss drug goes on sale next week. It's the only nonprescription diet drug approved by the FDA. It claims to help people lose 50 percent more weight than diet alone.NewsCenter 5's Heather Unruh reported Wednesday on the safety of the pill"I have lost 32 pounds so far," said Ruth Tenofsky, of Hull.After a six-year battle to lose weight, Tenofsky is tipping the scale in the right direction, with the help of a new diet program."It's exercise, eating properly and taking the pills," said Tenofsky.

Tenofsky is taking the diet drug Xenical, only available by prescription. But next week a lower-dose version of the pill, marketed under the name Alli, will be on store shelves. It's the nation's first nonprescription diet drug approved by the FDA."It's a safe plan and it also works," said Dr. Caroline Apovian, the director of the Center for Nutrition and Weight Management at Boston Medical Center.Alli is marketed for people over the age of 18. It claims to block the absorption of roughly 200 calories of fat."If you're able to lose 10 pounds using diet and exercise, you're able to lose 15 with Alli," said Apovian.Apovian has written "The Alli Diet Plan."

She stresses that Alli is not a magic pill. It needs to be used with a diet and exercise plan, and there are side effects. The biggest complaint: It can cause gastrointestinal problems."It's how the drug works, by blocking the fat. The fat has to go somewhere and it goes in your stool," she said.Tenofsky hasn't had any side effects. She understands the drug will not work on its own. She makes it a point to eat right, and get to Boston Pilates three times a week.

Diet Drug Orlistat (Xenical / alli) Better Choice Than Acomplia: British Experts

2007-05-31T07:09:00.000-07:00

Claims that diet drug rimonabant (Acomplia / Zimulti) offers benefits beyond those associated with weight loss may not be justified, according to a new report by independent British medical experts.

The diet drug has been sold as Acomplia in the U.K. since June 2006 for treatment of obese and some overweight adults, and developer Sanofi Aventis has claimed some of the improvement in cardiometabolic risk factors observed in clinical trials cannot solely be attributed to weight loss.

Cardiometabolic risk factors -- including low HDL (good) cholesterol, high LDL (bad) cholesterol, elevated fat levels in the blood, high blood pressure and insulin resistance -- in combination increase a person's chance of developing heart disease and/or type 2 diabetes.

Acomplia "has a beneficial effect on blood glucose and lipid levels -- a more beneficial effect than would be expected from weight loss alone," Sanofi claims on its website.

But experts writing in the Drug and Therapeutics Bulletin (DTB), published by the British Medical Journal (BMJ) on May 30th, said there was no proof in the clinical trials that Acomplia had any beneficial effects outside those expected by weight loss.

"It might be related to increased activity based on the lifestyle advice given to participants at the start of the trials," according to their report. "Furthermore, it is not known whether rimonabant's effects on individual risk factors translate into a reduced long-term likelihood of cardiovascular events."

The experts said the trials also showed rimonabant to have no effect on LDL cholesterol and little or no effect on high blood pressure.

While the drug is available in the U.K., the country's National Institute for Health and Clinical Excellence (Nice) is still weighing whether and under what conditions the drug should be paid for by the National Health Service.

"Rimonabant has not been directly compared with other, less expensive, drug treatments for obesity. Also, as with these other treatments, it is not known whether rimonabant reduces the likelihood of obesity-related diseases, such as cardiovascular problems," the researchers concluded.

They said Xenical (orlistat) "is the drug for obesity for which there is the most evidence for efficacy and safety to date, and we have previously concluded that it is a reasonable option for obese patients where diet and exercise and/or behavioural measures alone have failed.

"On current evidence, we do not believe that rimonabant represents a significant advance for patients with obesity," they said.

Over The Counter - Alli Diet Pill

2007-05-29T11:44:00.000-07:00

You won't lose weight in your sleep or shed pounds while eating anything you want - that's the sobering message from the maker of a weight loss pill poised to hit shelves next month.

While the cautionary marketing approach may not trigger stampedes to the counter, analysts say the drug's fate hinges on the pharmaceutical giant's ability to convince people that diet pills aren't a magic bullet. "People's hopes are ridiculously high when it comes to diet pills. That leads to disappointment and bad word of mouth," said Steven Brozak, an analyst with WBB Securities.

That's just what happened to the prescription version of the drug, Xenical by Roche Holding, which contains twice the dosage. People were let down when it failed to deliver dramatic results and the drug never really caught on, Brozak said.

GlaxoSmithKline has apparently learned the lesson and is counting on alli to become a star money maker. The company is spending $150 million on marketing alli this year, making it one of the drug maker's biggest campaigns to date. "We've done everything to go out of our way to be honest," said Steve Burton, vice president of the weight control division at GlaxoSmithKline Consumer Healthcare. "We're taking a very different approach than the fad diets people are constantly exposed to."

In clinical trials, the FDA says that people using alli lost an additional 2 to 3 pounds for every 5 pounds lost through diet and exercise. The FDA approved alli to be sold over the counter in February. When taken with meals, the drug blocks the absorption of about one-quarter of any fat consumed. That fat - about 150 to 200 calories worth - is passed out of the body, potentially resulting in loose stools.

About half of patients in trials experienced gastrointestinal side effects, including leakages and oily discharges. GlaxoSmithKline is frank about those unpleasant effects, which it says can be controlled if the drug is used properly. The campaign stresses the importance of keeping meals under 15 grams of fat to avoid effects.

Educational materials even recommend people start the program when they have a few days off work, or to bring an extra pair of pants to the office. Experts say a failure to adequately prepare consumers about the effects contributed to Xenical's limited success.

The alli event comes a day after the company's shares dropped almost 8 percent when a report this week found the company's widely prescribed diabetes pill raised the risk of heart attacks and possibly death. Some experts called it another Vioxx-like example of the U.S. government failing to protect people from an unsafe drug.

Glaxo shares rose 1.4 percent to $53.90 on Tuesday. The company estimates 5 million to 6 million Americans a year will buy the drug, translating to at least $1.5 billion a year in retail sales.

The drug will come in "starter kits" containing a food journal, a healthy eating guide and a fat and calorie reference guide. A 60-capsule kit will cost about $50 while a 90-capsule pack will cost about $60. Recommended usage is one to three pills daily.

Labeling indicates alli is appropriate for anybody who is overweight, or has a body mass index of 25 or higher. A body mass index over 30 is considered obese. Two-thirds of the U.S. population is estimated to be overweight or obese.

Just how many people find alli's benefits worth the cost of the drug is the "million dollar question," said Kelly Brownell, a food policy researcher at Yale University.

Diet drugs don't deliver the big results most people expect, and are only effective when used along with diet and exercise, Brownell said. The alli exhibit in New York City - featuring plates with sensible portion sizes and an interactive Web site - encapsulates the drug maker's marketing emphasis on that need for diet and exercise.

To prepare for alli's launch in mid-June, the company ran television spots directing viewers to a Web site where they could learn more about the drug. A retail book was also made available. The idea, Burton said, was to give "people some pause" and time to learn about the drug.

The message that alli isn't an easy fix marks a step in the right direction for pharmaceutical companies, said Michael Santoro, a professor of business ethics at Rutgers University. "One of the things we've seen so often in advertisements is that a drug can be an alternative to a healthy lifestyle," Santoro said. Still, he questioned whether a diet drug had any role in a campaign about healthy lifestyles.

Glaxo Vice President with new about to launch Alli Diet Pill

2007-05-25T11:30:00.000-07:00

Steven Burton, vice president weight control division of GlaxoSmithKline Consumer Healthcare, displays a starter pack of alli, the first over-the-counter diet pill approved by the Food and Drug Administration, in New York, Tuesday, May 22, 2007. In clinical trials, the FDA says that people using alli lost an additional 2 to 3 pounds for every 5 pounds lost through diet and exercise. (AP Photo/Richard Drew)

Alli Debuts are all Set

2007-05-23T11:49:00.000-07:00

Today, GlaxoSmithKline Consumer Healthcare introduces a new approach to weight loss that will debut through a public multi-media exhibit in New York City -- the alli(TM) Experience. The alli Experience represents part of GSK Consumer Healthcare's comprehensive educational program to prepare adults interested in losing weight with alli -- the only over-the-counter weight loss product approved by the U.S. Food and Drug Administration (FDA) -- before it goes on sale in pharmacies and mass retailers beginning on or about June 15. The alli Experience will be open daily beginning Tuesday, May 22 through Sunday, June 10, 2007, and is open Monday through Fridays from 11 a.m. until 6 p.m., Saturdays from 10 a.m. until 6 p.m. and Sundays from 11 a.m. to 5 p.m. The exhibit is located in New York City at 20 Union Square East

More than two-thirds of the U.S. population is overweight or obese, resulting in increased risk for serious diseases such as heart disease, diabetes, cancer and stroke. These serious health complications require the American public to take an honest look at the realities of weight loss. "We are here today to unveil the alli Experience and demonstrate our commitment to changing the way people think about weight loss," says Steven L. Burton, vice president, Weight Control, GlaxoSmithKline Consumer Healthcare. "People are fed up being bombarded with hyped products and fad diets that over promise and under deliver. Unlike all the hype, alli is about straight talk and an honest voice, being real about the fact that losing weight is hard work." Burton adds, "We are here to help and to partner with people who want to lose weight with a realistic approach. But we are not the total answer. The answer is individual commitment in partnership with alli, and all the support and education the alli program offers."

The alli Experience is designed to help overweight people revisit and engage the principles of modest, gradual weight loss. The exhibit, divided into five zones, begins with a sensory tour that leads to an interactive journey and multi-media education about weight loss realities. Each zone encourages visitors to embrace a more realistic approach to diet and exercise for improved health. Visitors receive meal planning ideas, delicious low-fat recipes and shopping lists with nutritious foods to help support a healthier lifestyle. The alli Experience will also help overweight people who want to lose weight determine if they are ready to commit to the alli program.

The alli Experience is open to anyone who is 18 years or older, as alli is for overweight adults. The exhibit will be closed Memorial Day. An online virtual tour of the exhibit will be available online beginning May 24 at myalli.com ( http://www.myalli.com/ ). For more information about alli and the alli program, go to http://www.myalli.com/ . About alli(TM)

alli, the only FDA-approved weight-loss product available to consumers without a prescription, combines a clinically-proven product with a comprehensive individualized action plan. The alli program encourages modest, gradual weight loss, known by experts as the best way to lose weight. alli is expected to be available in pharmacies and mass retailers nationwide beginning on or about June 15.

About GlaxoSmithKline Consumer Healthcare
GSK Consumer Healthcare is one of the world's largest over-the-counter consumer healthcare products companies. Its more than 30 well-known brands include the leading smoking cessation products, Nicorette(R), NicoDerm(R) CQ and Commit(R) as well as many medicine cabinet staples, including Abreva(R), Aquafresh(R), Sensodyne,(R) Tums(R) and Breathe Right(R).

About GlaxoSmithKline
GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: http://www.gsk.com/ . GlaxoSmithKline Consumer Healthcare

Pills or Surgery for Weight Loss?

2007-05-20T11:51:00.000-07:00

Lap-Band is short for laparoscopic adjustable gastric banding. It's an operation. Through small incisions in the abdomen, a surgeon inserts a viewing scope (laparoscope) and instruments with which he or she can encircle the top of the stomach with an adjustable band. That creates a small pouch for a stomach. People cannot eat large quantities of food. They fill up quickly. They lose weight.

The "pros" of this operation include a considerable weight loss, which brings protection against diabetes, high blood pressure and arthritic knees and hips. Cholesterol almost always drops.

The "cons" are the fact it is an operation, and all operations have the potential for complications. It requires anesthesia, another possible risk. The band might need readjusting down the road. There's always a threat of infection from any surgical procedure.

Orlistat has been around for some time and is sold as the prescription drug Xenical. Alli can be obtained without a prescription. It contains a smaller dose of orlistat. This medicine inhibits the intestinal enzyme lipase, which breaks up fat so that it can be digested. Less fat is absorbed. Weight is lost. A major "pro" for Alli is not having to undergo surgery. Some "cons" are possible loose stools, an increase in gas and a decreased absorption of vitamins A, D, E and K, which require fat to pass into the blood. That can be remedied by taking those vitamins in pill form.

Alli Diet Pill (Low-Dose Xenical) to Go on Sale June 15th

2007-05-18T10:34:00.000-07:00

Diet pill alli (low-dose orlistat) will officially go on sale on June 15th, according to distributor GlaxoSmithKline Consumer Healthcare.

While the pricing of the drug has not been officially announced, a starter pack that includes 60 alli capsules (enough for three weeks assuming that you take one before each meal), the alli Shuttle (a carrying case for your pills), and several booklets including a calorie and fat counter and a daily journal is expected to cost between $50 and $60.

An alli starter pack that includes 90 alli capsules (enough for a month assuming that you take one before each meal) is expected to cost between $65 and $70.

An alli refill package -- consisting solely of 120 alli capsules (enough for 40 days) -- is expected to cost between $75 and $85.

Glaxo, meanwhile, has released the first two television commercials of what is ultimately expected to be a $100 million plus first-year blitz for the first FDA-approved over-the-counter diet drug.

Both of the first two commercials can be viewed by those who have missed them on television via the video sharing website YouTube.

As part of the prelaunch educational campaign for the diet pill that Glaxo agreed to at the insistence of the FDA, the first two commercials are very slick but soft-sell and are designed to push people to Glaxo's internet website, myalli.com, which is expected to play a major role in the company's marketing.

Sweden Girls waiting for Alli Diet Pill Arrival

2007-05-15T06:56:00.000-07:00

Sweden is facing a surprising statistic: its girls are more likely to be overweight than are the boys. A study found that 4-year-old girls are six times more likely to be obese than they were 20 years ago, which is a much bigger jump than boys of the same age had. In 1982, 1 percent of all 4-year-olds were obese, compared to 2 percent of boys and 6 percent of girls in 2002. A similar discrepancy is found in 10-year-olds, but researchers don’t know why more girls are heavy

Researchers in America are looking at a new way to slow the rate of obesity by interviewing parents using a method popular for dealing with substance abuse. The technique, known as motivational interviewing, was used in a pilot program with 91 children of varying weights, all of whom had at least one obese parent. Some parents received a motivational interviewing session, while others received handouts or more intensive sessions with pediatricians or nutritionists. The difference in weight loss between the groups was not significant, but 94 percent of parents involved in the interviews said they helped them think about changing eating habits

One town in Massachusetts has recently completed a program to combat childhood obesity there. The Shape Up Somerville program was designed by researchers at Tufts University and involved a communitywide effort to make kids healthier. Initiatives included training school food service personnel, offering after-school cooking and physical activity classes, in-class nutrition and physical activity, and more. Students on average were prevented from gaining about a pound in an eight-month period, which doesn’t sound like much, but researchers say such small changes could have a big impact across the community

Alli, the new over-the-counter weight-loss pill from GlaxoSmith Kline that’s set to hit shelves next month, is not a miracle pill, nor is it being marketed like one. Ads and the website for the drug emphasize that people need to work to see results with the pill. The company wants people to know Alli is not intended to be another diet drug that’s heavy on promises but doesnt actually work

Finally, it seems a group of female students at Framingham State College thought better of their plan to wear tank tops and shorts to a women’s lacrosse game while sporting a player’s name spelled out on their bellies. The women are accused of stealing 1,000 copies of the school newspaper in which a picture of them appeared, apparently because they thought they looked fat. The adviser for the newspaper said the incident “is the most stupid reason the paper has been stolen.”

Alli Diet Pill needs no prescription but won't work without exercise and healthy eating

2007-05-09T07:34:00.000-07:00

For many overweight Americans, the battle of the bulge didn't begin with great drama. Too many fast food dinners and long work hours that squeezed out time for exercise led to gradual weight gain and, eventually, a weight problem with serious health risks.

Within weeks, some of those pudgy Americans may reach for Alli, the nation's first over-the-counter diet remedy approved by the Food and Drug Administration. The manufacturer, GlaxoSmithKline Consumer Healthcare, has been strategically placing 1 million copies of self-help diet books that will sit on store shelves until late June, when they'll be replaced with packages of Alli as the diet pill goes on sale nationwide.

But for all of Glaxo's marketing might, Alli won't work unless consumers who buy it also commit to lifestyle changes. That means choosing healthy, low-fat diets and exercising. The trio maximizes weight loss: For every 10 pounds the overweight consumers would lose, adding Alli would increase that weight loss to 15 pounds. Alli alone won't do the job.

Ruth Tenofsky has already learned that lesson. The Jamaica Plain woman is working on losing an extra 10 pounds, on top of the 35 she's already shed. Tenofsky knows exactly how she put on that extra weight. After her son moved out of the house, Tenofsky, a real estate broker, and her husband frequently went out for dinner.

It didn't stop there. "I am a grazer by nature," she said. "I sort of figure if you eat it standing up, it doesn't count. I would eat a cracker. Only it wouldn't be a cracker, it would be the whole box."

A few months after those excess pounds dampened her enthusiasm for a vacation trip to the beach, she resolved to take action last fall with the assistance of Dr. Caroline Apovian , director of the Nutrition and Weight Management Center at Boston Medical Center.

"I said, 'I've got to learn to eat properly,' " recalled the 62-year-old. "Like a lot of women my age, we lose sense of what a portion size is." She lost the weight through a combination of improved diet, a commitment to exercise, and Xenical -- a prescription version of the drug that will be sold over the counter, at a lower dose, as Alli.

But Tenofsky does not credit swallowing a magic bullet for her magical transformation. She's on the treadmill two or three times a week and takes Pilates another two or three times a week. She's banished crackers and pretzels and replaced them with fresh fruit. She and her husband still eat out, but "grilled, steamed, broiled, sauce on the side" has become her mantra.

GlaxoSmithKline's gamble is that over-the-counter users will be as committed to lifestyle changes as Tenofsky is.

At 60 cents per pill, Alli helps burn 150 to 200 calories, about what you'd down in a quarter-cup of Ben & Jerry's New York Super Fudge Chunk ice cream. It's also the amount of calories one could burn for free, by taking a brisk walk for 15 minutes and gardening for another 15 minutes.

People will take Alli three times a day, with meals that contain about 15 grams of fat. (That's the amount of fat in two tablespoons of peanut butter.) Alli works by blocking fat absorption. Eat too much fat, however, and the drug's dreadful side effects can kick in: oily gas and such sudden, uncontrolled bowel movements. Glaxo suggests that new Alli users wear dark apparel and have a change of clothes ready.

Still, Edward Jones analyst Linda Bannister projects that Alli will carve out $200 million in annual sales, because Americans are hyper weight-conscious. "It's not for everyone," Apovian cautions. "It is certainly not for the person who wants to lose 10 pounds tomorrow -- no way."

Alli Diet Pill Book Launched

2007-05-06T09:57:00.000-07:00

The makers of the first government-approved non-prescription weight loss drug have launched a book to help consumers maximize their weight loss potential by taking on a healthier lifestyle.

The book, Are You Losing It? Lose Weight Without Losing Your Mind, was born out of an agreement between GlaxoSmithKline, the nutritional supplement company that created the diet pill Alli, and the United States Food and Drug Administration. The federal food and drug regulator voiced concerns about the misconceptions consumers might have about how the pill actually works. The book, on supermarket and pharmacy shelves across the country, is meant to educate Alli users about the need for exercise and adopting a low-calorie diet.

Alli is expected to be available to the public this summer. The drug is designed to work by blocking the absorption of fat by the body and limiting the number of calories that are absorbed. Alli users are expected to lose up to 10 percent of their body weight when they use the pill in combination with a reduced calorie diet and an exercise program.

Book on Alli Diet Pill (Low-Dose Xenical) Now Appearing on Stores

2007-05-03T09:23:00.000-07:00

The long anticipated launch of diet pill alli (low-dose Xenical) has now been preceded by launch of the new official alli book -- called "Are You Losing It? Losing Weight Without Losing Your Mind" -- which began making a May debut on shelves of grocery stores and pharmacies all across the country.

The book is part of the premarketing educational campaign for the diet pill agreed to by Glaxo Smith Kline before the Food and Drug Administration okayed alli as the first and only FDA-blessed weight-loss product that will be available to consumers without a prescription.

The FDA was insistent that consumers not be led to view alli as a "magic pill" but be educated to the need to combine it with a reduced-calorie diet and exercise program, and the book gives practical advice on behavioral changes, provides low-fat menu ideas and offers physical activity tips.

The book retails for $5.99 and Glaxo said consumers will find it -- as long as supplies last -- in the weight loss product aisle at stores nationwide including CVS, Walgreens, Kroger, Target and Wal-Mart.

"This book provides a much needed educational tool that takes you on a thoughtful journey about simple lifestyle changes that may deliver big health benefits," says Gary Foster, Ph.D., contributing author, director for the Center for Obesity Research and Education and professor at Temple University.

Other experts contributing to the book are:

Dr. Caroline Apovian, director of the Center for Nutrition and Weight Management at Boston Medical Center .
Kathleen Daelemans, a professional chef who focuses on healthy eating.
Dr. Madelyn Fernstrom, director of the Weight Management Center at the University of Pittsburgh Medical Center .

AN ALLY FOR OVERWEIGHT AMERICANS?

2007-04-29T09:32:00.000-07:00

Alli can help overweight Americans shed extra pounds, but should not be considered a miracle drug, said Malesia Dunn, a GlaxoSmithKline spokesperson. Consumers will also have to follow a reduced-calorie diet and commit to regular exercise to see results, she said.

"Now, instead of [losing] 10 pounds, by including Alli in that program, you will potentially lose up to 15 pounds," Dunn said. "And for a lot of people that becomes very meaningful."

The drug's active ingredient decreases the body's absorption of fat by about 25 percent per meal -- meaning that dieters do not absorb those fat calories. The undigested fat passes through the body and can cause unpleasant side effects, including gas, oily spotting and loose stools. The FDA recommends that users follow a low-fat diet to reduce these side effects.

"If you eat a lot of fattening, high-fat products, you're still going to have a lot of that in your body," Dunn said. "The product only blocks a percentage."

Dunn said GlaxoSmithKline has spent a great deal of time and marketing to educate consumers about how Alli works. Even the drug's website, www.myalli.com, tells potential customers that losing weight "won't be easy -- nothing worth it ever is -- but greater weight loss is possible."

"Alli's just going to help you with that payoff," Dunn said.

GlaxoSmithKline has also funded the production of a new book to educate overweight consumers about weight loss, according to an April 30 GlaxoSmithKline press release. The book, titled Are you Losing it? Losing Weight Without Losing Your Mind, provides dieters with weight-loss strategies, low-fat menu ideas and advice on how to make lifestyle and behavioral changes, according to the press release. The company's website for Alli also includes a Body Mass Index calculator and "Alli readiness quiz" that helps potential consumers determine whether they should use the drug. Only people ages 18 and older who have BMI of 25 or higher should take Alli.

If taken three times per day, Alli will block about 100 to 200 calories daily, Dr. Caroline Apovian, a Boston University medical professor said. Apovian endorsed the drug on its website and contributed to GlaxoSmithKline's weight-loss strategies book.

"I decided to endorse Alli because it is the safest and most effective FDA-approved weight-loss drug to go over the counter," she said.

Although the FDA considers the drug to be a safe and effective weight-loss aid, some people said Alli's intestinal side effects make the pill an unattractive option for weight loss.

"I just would never want to use it," said Donna Devlin, an administrative secretary at BU's Office of Career Services. "I wouldn't want to have the side effects. It doesn't seem worth it."

Alli: Is This the Magic Pill That’ll Drop Down Your Dress Size in Weeks?

2007-04-17T08:33:00.000-07:00

People have been waiting for years for some sort of a magic pill that could help them lose weight without any effort. The FDA has approved the first over the counter(OTC) weight loss pill Alli which means you don’t need any prescription to buy them.

The makers of the pill, Glaxo Smithkline claim that the drug apparently cuts weight by 5 per cent in only four months and also improves the overall health by reducing blood pressure and cholesterol levels.

How does it work? According to the website- The Alli capsule works by preventing your body from absorbing some of the fat you eat. When you take the capsule with meals, Alli prevents the enzymes in your intestines from digesting about one-fourth of the fat in your foods. Undigested fat can’t be absorbed and passes through your body naturally. Which means your body can’t store it as fat. If you could lose 10 pounds through dieting alone, you could lose 15 with alli.

All weight loss pills come with side effects; according to the makers, you may have gas with oily spotting,loose stools and more frequent stools that may be hard to control.

Taking a Pill to Make Eating Fat Painful

2007-04-17T08:26:00.000-07:00

If you remember Olestra (a fat that was unabsorbed by the body) and its side effects, you will know what the deal is with Alli. In February this year, the FDA approved GlaxoSmithKline’s “Alli” an over-the-counter version of prescription orlistat (Xenical). It is a drug that blocks enzymes that break down fat, preventing the body from absorbing fat from ingested foods. The side effects of the drug are the extremely uncomfortable effects of not absorbing fat: fatty stools, fecal urgency and gas. Obviously these side effects are triggered by ingestion of fats, so the Alli Web site (www.myalli.com) encourages users to think of these “treatment effects” as an “incentive to keep from eating too much fat.”

What I don’t understand is, if the idea is to prevent you from eating fat, isn’t that just a diet? Moreover, the Web site also has a “readiness quiz” for the drug regimen. You are deemed ready to go on Alli if you are willing to commit to the hard work it takes to lose weight, eat smaller portions, eat a reduced-calorie and low-fat diet, and be more active. If you are doing these things, you are on a diet, so why would you want Alli and all its unpleasant effects?

Naming the drug to sound like a cute little girl’s name makes it all too transparent who GlaxoSmithKline is targeting. Where orlistat was only suggested for prescription to the extremely obese, half-strength Alli can be snatched up by any woman who is unhappy with her body image. Although Alli is only suggested for those above a certain BMI, the potential for abuse seems pretty blatant. On the other hand, obesity is a real and growing health threat in America. Anti-obesity drugs are sometimes viewed as tools to psychologically empower people to lose weight. If Alli can produce results and sustain them, then more power to it. My inner skeptic says loose stools and fecal urgency does not seem like a sustainable option.

Drugs sold over the counter present dangers

2007-04-10T08:31:00.000-07:00

Over-the-counter drugs offer a variety of cures for what ails the average college student, including problems such as coughs, yeast infections and headaches.

But college-aged students, especially women, need to be careful and critical of emerging OTC drugs, health officials warn. Some could have negative consequences, despite the fact that the Food and Drug Administration deems them safe for use without the consent of a doctor.

The FDA has no systematic way of tracking negative effects of OTC drugs yet, so patient responsibility is important, said David Brushwood, University of Florida professor in pharmacy health-care administration.

Concerns arise, for example, when looking at the new OTC drug, Alli, made available this summer. Alli, pronounced "ally," is the first FDA-approved, OTC weight-loss drug.

The drug, taken with meals, blocks intestinal enzymes from digesting one-fourth of food's fat.

"Let's face it. There is pressure in our society to be thin," said Mary Ann Burg, associate professor of Community Health and Family Medicine and former director of UF's Women's Health Research Center.

Weight-loss pills may seem like one route to get to that socially acceptable norm.

Yet, research shows that college-aged women diagnosed with bulimia can be frequent abusers of laxatives, or OTC stimulants that treat constipation, as a means to increase weight loss, Burg said.

Drugs treating more overt female concerns and problems have also made transitions from prescription to OTC, sometimes only after political pressure, said Phylis Craigcq, nurse practitioner at the Women's Clinic at the Student Health Care Center.

In 1991, women were allowed buy treatment for yeast infections over the counter. And last fall, the morning-after pill, or Plan B contraception, won approval for OTC use after the FDA duked it out with Congress and its own advisory board.

"We have a lot less girls sitting on our doorstep Monday morning, and our emergency calls sure have gone down," Craig said. "I don't miss those 2 a.m. phone calls."

Morning-after pills became available upon request in January, after the manufacturer re-packaged and re-labeled the drug - a major concern of the FDA, Craig said.

"The FDA is a label-oriented organization," health administration professor Brushwood said. "They say, 'Can we write a label so clear, so easy to understand that a consumer can use it without medical assistance?'Â "

Clear labels describing safe usage are one of the primary factors the FDA uses to decide if a drug should be offered over the counter, Brushwood said. If the drug company can't provide a legible label, its product becomes prescription only.

It has to have adequate directions, warnings and advice that consumers could understand and follow, he said.

Yet, even after precautions have been taken, the FDA could still have a problem on their hands.

"The truth is, every drug has side effects and the potential to cause harm," said Earlene Lipowski, an associate professor in the College of Pharmacy.

Both Lipowski and Brushwood agree that the FDA has no concrete, systematic method of catching abuse of OTC drugs.

The system in place now is completely voluntary, Brushwood said.

Here's how it works:

A patient takes a cough medicine, which gives him hives all over his body. Shocked and surprised, he goes to his doctor, explains what cough medicine he took and what happened to him.

The patient goes home, and the doctor has a choice. He can go about his day, or he can send a "moderator report" to the FDA, describing the patient's situation.

The FDA - if the patient isn't the only one with hives from this cough syrup - develops an aggregate of similar cases and if it becomes large enough, goes to the drug manufacturer to investigate what is happening.

Further research interprets whether that cough syrup stays on the market.

"You see, though, patients have a responsibility in all this as well. They have a responsibility to report adverse reactions" to a doctor, nurse, pharmacist or other health-care provider, Brushwood said.

The best way to use any drug - prescription or over the counter - is to check with a doctor first, women's health researcher Burg said.

Sometimes, going to a health practitioner, even if you know what you need, can help you in the future, as well, Craig said.

For instance, when the morning-after pill was only available by prescription, the Women's Clinic staff used to have ways of counseling sexual assault victims or setting up prescriptions for oral contraceptives so patients wouldn't need to use the morning-after pill again.

Even though she supports the drug being over the counter, it's harder to provide further help to patients who come in, pick up the drug and leave after only a minimal interaction with a pharmacist, Craig said.

Diet Pill alli May Also Be Available Over-the-Counter in Europe by Late 2008

2007-04-03T07:03:00.000-07:00

Diet pill alli, which is scheduled to go on sale in the United States in mid-summer, may also be available as an over-the-counter diet drug in Europe by the end of next year, according to GlaxoSmithKline.

The company said on April 1st that it plans to seek European approval before the end of this year to sell alli, a low-dose version of prescription diet drug Xenical (orlistat), and hopes to launch the drug in Britain and other European countries by late 2008.

The U.S. Food and Drug Administration gave the go-ahead to alli in February, making it the first weight-loss pill ever approved for over-the-counter sale in the United States.

In Europe as in the United States, hundreds of unregulated products are sold as diet aids in pharmacies and supermarkets, and Glaxo is counting on the blessing by regulators to set alli apart and lead to its use by millions of dieters.

"Consumers spend billions each year on fad diets, unproven miracle pills and potentially unsafe weight loss supplements that may not work," a Glaxo spokesperson said.

"alli is the clinically-proven alternative to these hyped quick-fix products that mislead overweight adults away from weight-loss strategies that are backed by medical science."

"My concern is that it should not be seen as a panacea for people who want to get into a smaller-sized bikini," said Dr. Colin Waine, chair of Britain's National Obesity Forum. "It may also be unpleasant - if you eat a high fat diet you will experience the effects. But if used sensibly with the right sort of dietary back-up then this could help some people."

Wonder weight loss drug to go on sale in UK next year

2007-04-03T07:02:00.000-07:00

The battle of the bulge is soon to get a drug-fuelled boost. The first over-the-counter weight loss pill has been licenced in the US and is expected to be approved for use in Britain next year.

Alli, marketed by GlaxoSmithKline, will join dozens of other slimming aids sold in chemists and supermarkets. But unlike them, Alli has been proved to work.

Clinical trials have shown that when combined with a low fat diet and exercise regime over six months, Alli can increase weight loss by 50%, Jean Paul Garnier, head of Glaxo said.

In the US, the Food and Drug Administration gave the go-ahead to Alli last month, triggering a marketing campaign which the company hopes will reap five to 6mn US customers a year.

At a price between $12 and $25 a week (£5-£12), the drug could have annual sales of $1.5bn.
Glaxo said it planned to apply for a European licence by the end of the year with the launch of the drug expected to follow within 12 months. Alli is an over-the-counter version of Xenical, the prescription weight loss remedy launched by the Swiss pharmaceutical company, Roche, in 1999.

Alli contains half the dose of Xenical and will be packaged with guides giving advice on meal planning, what to order when eating out, a fat and calories counter and a journal to record daily food intake.
Two thirds of adults are overweight or obese and the numbers are continuing to rise. Experts believe diet and discipline are not alone sufficient to prevent waistlines expanding and that extra help is required.

The drug works by blocking the absorption of fat from food that is eaten. About one quarter of the fat is blocked with prescription-strength Xenical, but the effect will be reduced in lower strength Alli.
However, the unabsorbed fat has to go somewhere and dieters using it are prone to diarrhoea, its least attractive side effect.

Steve Burton, the Glaxo executive in charge of promoting Alli in the US, has used the drug himself and describes in painful detail the embarrassment it caused when he ate a fish and chip meal with tartare sauce.
The result was a “classic oops” and a dash home for a change of clothes, he told reporters last year.
On the other hand, the drug’s effect provides a powerful incentive to stick to a low fat diet - because the consequences of doing otherwise will be too unpleasant.

Burton, 48, is a walking advertisement for the drug’s success - he lost 65lbs over three years, cutting his weight from 275lbs to 210lbs.
But he warned he had done better than the typical user will do because he had been particularly faithful to his diet and exercise regime. Evidence from trials of Xenical also show that weight loss is temporary - and tends to be re-gained once the drug is stopped.

A spokeswoman for Glaxo in the UK said: “Alli is a fantastic drug if taken alongside a low fat diet and you have a lot of willpower. But it is not a wonder pill and it won’t achieve weight loss on its own. It will be marketed in a very similar way to our smoking control programme where NiQuitin (nicotine gum and patches) comes with advice on giving up smoking, a website and regular messages of support.” – The Independent

UF experts urge caution with diet pill called Alli

2007-03-26T07:32:00.000-07:00

University of Florida health experts caution students about a former prescription diet pill that blocks the absorption of fat.

The pill recently approved by the Food and Drug Administration for sale over the counter is a reduced-strength version of Orlistat and will be sold as Alli.

Anne Kendall, a lecturer in the Food Science and Human Nutrition Department, said the pill blocks the absorption of fat consumed and the fat is then transferred to the stool.

Kendall said the pill is not a "magic bullet."

According to the Alli Web site, for every 5 pounds lost from dieting, Alli can take off an additional 2 to 3 pounds.

Kendall said the pill can cause diarrhea and deficiencies in vitamins A, D, E and K, but a multivitamin can help.

Kendall explained that Alli was probably approved because the research didn't present dangerous side effects since it's a lower dose. "One of the key things is to use it as directed," she said. "There's no guarantee that people won't take larger doses than recommended."

A larger intake of the pill could leave the organs unprotected because more fat is being blocked, she said.

Alli alone won't block all the fat absorption, which is why diet and exercise is required, she said.

Mark Murphy, a personal trainer intern at the Department of Recreational Sports, said he would warn anyone he was training against using artificial products. He said he thinks anyone using a weight-loss pill is avoiding a workout.

Murphy said he dealt with a female student who used a diet pill and lost 7 pounds in two weeks to prepare for Spring Break. During the break the student regained the weight because she had only shed water weight. He explained she became sick because of dehydration and alcohol.

He said just because a person looks good on the outside, it doesn't mean they're healthy inside. He said it's important to monitor heart rate, blood pressure and bowel movements, if using a diet pill.

Mariana Fonseca, 19, a dietetics major, said she doesn't know if Alli will become popular on campus, but she does not support the use of diet pills.

Exercise and diet alone are the healthiest ways to lose weight, even for those who are obese, she said. "People are going to think this is a miracle pill and that's bad because it's not," she said. "It's healthy to lose 1 or 2 pounds a week."

Fonseca counts calories and exercises as part of a regimen for a health condition that can cause her to gain weight. "Whatever you put into your body is what you get out of it," she said.

Diet Pill alli Begins Recruiting 400 Would-Be Dieters for Prelaunch Test

2007-03-26T07:27:00.000-07:00

Diet pill alli (low-dose Xenical) has begun recruiting 400 would-be dieters for a prelaunch test of educational program being designed to support the first FDA-approved over-the-counter diet drug.

Several readers of our sister site, alliReport.com, report they have received emails inviting them to apply to become part of something called the alli First Team Community, which is built around a password-protected online forum.

"As a member of the alli First Team community, you will be provided with the only FDA-approved weight loss product (alli capsules), educational materials and tools to help you on your journey, and an on-line community to support your efforts," the email said.

"If you are selected to join this community, we ask that you read the materials that we’ll send you to help you get ready, take alli with each meal containing fat, keep a daily food journal, log in to the community and contribute your thoughts (via surveys, bulletin boards, chats, etc.) at least once a week.

"You can expect to spend 10-15 minutes online per week. In addition to sharing tips and building friendships with other members, you will receive a free supply of alli for 6 months," the email added.

GlaxoSmithKline said it would send participants the first 3-month supply of the diet pill prior to its being available in stores, suggesting -- since next week is April -- that alli will not be generally available until at least July.

The email also indicated that participants in the trial who follow the alli program and are successfully losing weight may also be asked to become part of the alli public relations program and speak to members of the media about their experiences.

If you are selected for the alli First Team community, please keep the alliReport.com posted on your experiences.

Why Hoodia Beats Alli for Weight Loss?

2007-03-08T07:43:00.000-08:00

1) Alli won't be out till July 2007.

Well, how could Alli beat Hoodia if it isn't even in the market yet? Isn't it better to try something that's already been out in the market for a while and has been proven to work?

2) Alli is a drug whereas Hoodia is ALL natural and on the market since 2004!

For me, the natural way is always better. I'm actually paranoid about using diet pills especially when I heard some speculations that diet pills may have caused the death of Ana Nicole Smith. If you ask me, I'm scared of drugs!

3) Alli costs more than Hoodia.

The cheaper the better!

4) Hoodia has NO known side effects whereas Alli's active ingredient is 60 mg of Orlistat. Consequently Alli has side effects which include: gas with oily discharge, spotting, loose stools, and more frequent stools that might be hard to control, alli reduces the absorption of some vitamins, cannot be taken with a large list of other medications because it may interfere or cause further complications. I don't know about you but when I am at work, in bed with my wife, on the treadmill at the gym or sitting in the front row at church, getting hit with a dose of "oily discharge from a loose stool" would be quite a disruption.

Weight-loss drugs can't replace exercise, healthy eating

2007-03-08T07:40:00.000-08:00

The Food and Drug Administration's approval of a new over-the-counter weight-loss product sent dieters' hopes - and Phoenix physician Art Mollen's worries - soaring.

The drug orlistat, sold under the brand name Alli in 60-milligram capsules, was approved in February. It's also is available by prescription as 120-mg Xenical capsules.

The FDA says Alli should be used only by people 18 and older and in conjunction with a reduced-calorie, low-fat diet and an exercise program, but Mollen says he sees potential for abuse of the medicine.

Question: Who is likely to reach for these products?

Answer: There are literally millions of people in this country who want to lose weight. When someone tells them they're going to lose a lot of weight by taking a particular medicine, they're going to try it.

I think the most serious potential for abuse is among teenagers, including body-builders who want to get down to the leanest body weight possible and females who want to be thinner, and among people who have eating disorders like anorexia or bulimia.

Q: What controls are there for weight-loss products like these that are sold without a prescription?

A: Alli is designed to be taken up to three times a day with meals, and at 60 mg per capsule, it's supposed to be safer than Xenical. But if people take more, no one will know. The makers of Alli say that most people in their studies lost five to 10 pounds over six months. Even over-the-counter drugs supposedly can't make false claims, but questions have been raised about the accuracy of the studies.

Q: How does Alli work?

A: By blocking the absorption of some of the fat in your meals. In Xenical, the prescription version, orlistat blocks about 30 percent of the fat from being absorbed. There's a caveat stating that it won't work if you don't cut calories and start exercising. Well, we all know that.

Q: What are the side effects?

A: The most serious is loose stools. If you take Alli, you won't fully absorb fat-soluble vitamins like vitamins A, D and E, so you'll need to take a multivitamin. It shouldn't be used if you have diabetes or thyroid disease or take blood thinners.

Q: Have the safety and effectiveness of prescription weight-loss products been better?

A: Over the years they have included amphetamines, which are central-nervous system stimulators that speed up your metabolism and suppress your appetite. But as we've learned, there are numerous side effects, including elevated blood pressure, insomnia, increased pulse rate and heart palpitations.

The most famous of these was the fen-phen diet, which included the drugs fenfluramine and phentermine. That caused serious heart problems affecting the mitral (heart) valves. When it was banned, everyone who'd been taking the drug was advised to get an echocardiogram.

Q: How do the non-prescription drugs stack up?

A: TrimSpa is a popular one that has been in the news lately because Anna Nicole Smith was the spokesperson. It's basically a common blend of appetite suppressants, with nothing unique in it. Others contain ingredients like caffeine, the herb ma juang (a species of ephedra), guarana (a tropical berry extract) and green tea that pump you up.

These types of products can cause insomnia, hypertension, irritability and emotional highs and lows, and even increase the risk of stroke. Phenylpropanolamine (PPA), which was used in over-the-counter weight-control drugs and decongestants, was found to increase the risk of stroke sixfold. The FDA has removed it from the market.

Q: Do any of these products get at the root of the problem?

A: If there's a lesson to be learned, it's that exercise and diet are what help people lose weight and maintain the loss. I've had patients over the years who have lost 10 or 20 pounds with products like these and felt great, but inevitably, if they haven't changed their lifestyle, they regain the weight.

Is the new weight-loss drug worth trying?

2007-03-08T07:38:00.000-08:00

It's no longer convenient to purchase an effective decongestant these days, now that pseudoephedrine has been moved behind the counter. But if it's weight loss you're after, you'll soon be able to buy orlistat, a fat-blocking drug of limited effectiveness, with ease. In February the Food and Drug Administration gave manufacturer GlaxoSmithKline the green light to sell an over-the-counter version of the drug under the brand name Alli. Alli is half the dose of prescription orlistat, Xenical, which has been on the market since 1999.

With the move GlaxoSmithKline stands to snag a chunk of the $41 billion that Americans spend on weight-loss strategies each year. The company says Alli, which is slated to hit store shelves this summer, will cost $1 to $2 per day.

But if a pill that limits your body's ability to absorb fat from food seems a little too good to be true, you're on to something. The drug has several drawbacks.

For one, Xenical hasn't lived up to its promise; some doctors have found it to offer marginal benefit in clinical practice. At half the prescription strength, Alli is likely to be even less effective. Data presented to the FDA suggest that Alli works best in those who are very overweight, that it must be used in conjunction with a low-fat, reduced-calorie diet, and that results are modest. In clinical trials, severely overweight subjects who took the drug for six months lost about 5 pounds more than those taking a placebo. In a separate four-month trial, moderately overweight people lost about 2 1/2 pounds more than the control group. Benefits are also likely to be short-lived. Alli will be marketed for short-term use only, and follow-up suggests that people start to regain weight once they stop taking it.

Embarrassing side effects

Orlistat is notorious for what one FDA advisory panel member termed "the underwear problem." Unabsorbed fat can cause intestinal side effects such as fatty stools, oily spotting, flatulence with discharge, an urgent need to defecate, and frequent bowel movements.

Evidence suggests that the drug can also impede the absorption of fat-soluble vitamins. Users need to take a multivitamin daily at least two hours before or after taking orlistat, though in actual-use studies only about half managed to do so. Orlistat should not be used by those taking the blood thinner warfarin (Coumadin). People on diabetes medications should use it only under a doctor's supervision.

GlaxoSmithKline is including a guide to healthful eating and free access to an individualized online action plan with Alli starter packs. But while the advice might be worth taking, the pills might not be.

GlaxoSmithKline Allies With Web For Diet Launch

2007-02-28T07:05:00.000-08:00

As the maker of the first weight-loss drug with regulatory approval, GlaxoSmithKline faced a dilemma: how to differentiate its product, Alli, from the many fly-by-night remedies promising weight loss without effort. To get users to buy into its assertion that long-term weight loss can only be achieved in combination with lifestyle changes, the pharma company is taking a page from Yahoo and MySpace by constructing its own portal that in many ways resembles a social network.

To accomplish this, GSK is joining the ranks of advertisers that are using the Web to become content creators and build communities around their products, like Anheuser-Busch's ambitions with Bud.TV and the vibrant running community Nike has tapped with NikePlus.com.

For Alli, due to launch in June or July, the Web is not just a marketing conduit, but an essential component of the product. Unlike many diet pills, Alli is marketed as a complement to a strict diet and exercise regimen. The over-the-counter drug, which blocks fat production in the intestines, can increase weight loss by 50 percent, GSK claims. But only if users commit to a regimen of proper eating and exercise—a long-term lifestyle change—and a six-month program of the drug, said Steve Burton, vp of weight control for GSK's consumer healthcare division.

"It's an innovative and honest voice in a landscape that's filled with products that make exaggerated claims," he said.

GSK's interactive agency, Dallas-based independent imc2, has built a Web portal for Alli users that goes beyond providing product information. MyAlliPlan.com will be available to Alli users through a registration code on each packet. The site will collect the users' weight-loss profiles, build customized meal plans and provide feedback on their progress. Visitors will then get customized advice, with the system sensing, for example, if they have hit a wall in their weight loss and need to adjust their daily calorie intake. Message boards and blogs will let users advise and encourage each other, and advice from experts will be available.

"It truly is designed as a destination to help people not just educate themselves, but to help them along the way," said Beth Kuykendall, vp and managing director of imc2.

Although consumers are turning more and more to the Web for health information, there is evidence that there is a dearth of content to satisfy demand, said Larry Mickelberg, svp of strategy at Medical Broadcasting Company, a Digitas-owned pharma agency in Philadelphia. He noted that over 80 percent of Web users have searched for healthcare information, yet under 20 percent found satisfactory answers, according to a 2006 study from Jupiter Research. Pharma companies have the resources to fill that gap, he said. "There's already latent demand in the marketplace that's not being served by most pharmaceutical marketers," he said. "Their audience has beaten them to the Internet."

With that in mind, GSK launched QuestionEverything.com, a site dedicated to debunking myths about fad diets and weight-loss supplements, before Alli had received FDA approval. The site does not mention Alli, though it carries notice that it was built by GSK. Burton said the main purpose of the site was "public service," although it did collect visitors' e-mail addresses.

GSK is taking its publisher role a step further in its pre-launch marketing with the release of a 140-page book, Are You Losing It?, which aims to deliver sensible weight-loss information, and 20 pages of Alli background.

While GSK said it's keen to be seen as a trusted source of information about weight loss, pharma companies should tread lightly when doubling as content publishers, said Brad Aronson, evp at Avenue A/Razorfish. It is often more effective, even for new treatments, to partner with already trusted health publishers and communities, like WebMD and MayoClinic.com.

"They're not going to the pharmaceutical company to learn about a disease or condition," he said. "We want to be realistic that for conditions where there's a lot content out there they're not going to look to us for that content."

Diet Pill alli (Low-Dose Xenical) May Ultimately Be Marketed Worldwide

2007-02-24T10:04:00.001-08:00

Diet pill alli (low-dose orlistat), which earlier this month became the first FDA-approved over-the-counter diet drug, may ultimately be available in countries around the world.

Roche, which sells the prescription version of orlistat called Xenical, announced on Feb. 20th that it had granted GlaxoSmithKline an exclusive license to sell the half-strength version in countries outside the U.S. and Japan.

Roche had licensed the U.S. nonprescription rights to Glaxo in 2004.

Roche said it will retain all rights for the prescription version and will continue to market Xenical worldwide.

alli, which reduces the amount of fat the body absorbs from food, was approved by the FDA for use by overweight adults in combination with a reduced-calorie, low-fat diet and exercise.

Glaxo expects to have it on supermarket and drugstore shelves sometime in the summer.

First OTC obesity drug to be sold

2007-02-24T10:03:00.001-08:00

The pharmacy section in your local supermarket will soon carry another weight loss drug among the range of trim-this and slim-that. But the new addition will be the first over-the-counter weight loss drug approved by the Food and Drug Administration.

Alli, which are orlistat capsules marketed by GlaxoSmithKline, hits shelves nationwide in June.

"We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and type 2 diabetes," said Dr. Douglas Throckmorton, Deputy Director for FDA's Center for Drug Evaluation and Research, in an FDA news release. "[Over-the-counter] orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health."

Approval of this drug comes when obesity is rising at an "alarming rate," according to the American Obesity Association.

The National Center for Health Statistics says 30 percent of American adults 20 years old or older are obese. The percentage of overweight young people has more than tripled since 1980, according to their statistics, and overweight young people are likely to become overweight or obese adults.

The FDA originally cleared orlistat capsules for prescription use in 1999 to treat obesity. Pills with a higher doses of orlistat than the OTC version remain strictly by prescription.

Brian Jones, president of communications for GlaxoSmithKline, said since the drug's inception, 25 million prescriptions have been filled in 145 countries. Jones said patients saw 50 percent more weight loss with the drug than with diet and exercise alone.

"I just lost 30 pounds in six months just by dieting and exercising. If I had the product, just think, that would have been 45 pounds," Jones said.

Alli may be taken up to three times a day during mealtime. Nicole Whatley, University registered dietician, said dieters should divide their fat intake evenly throughout the day.

Specialists Caution About Diet Pills

2007-02-24T10:00:00.000-08:00

Further to FDA’s approval on the latest diet pill under the brand name Alli, there has been much excitement in people who are keen to bring down their weight. Alli has been given the status of over the counter (OTC) drug in the U.S.

This drug is said to block the absorption of fat by the body. Uncontrolled bowel movement and loose stools are reported to be the side effects of Alli.

In the Indian scenario, there are many drugs and alternate remedies to bring down one’s weight. Drugs under the brand name of Obego or Obestat are said to be targeting parts of brain which is responsible for hunger. But this could have serious contra indications like high blood pressure and pulse rate.

In the ayurvedic segment, many of the formulations are not clinically tested. According to Dr Gulhati, the editor of MIMS, such drugs are illegal as they will not be passed by the government unless they are prescribed by the classical books. The combination of right kind of food and exercise alone would help in bringing down one’s weight.

Medindia on U S Government Allows Non-prescription Diet Pill
The Food and Drug Administration has approved the sale of a diet drug which can be sold without a prescription. This weight loss pill is called Alli, which was previously sold as a prescription drug by the name Xenical since 1999 in U.S.

Lose weight or lose control

2007-02-24T09:58:00.000-08:00

Slimming effects of alli may trigger many unpleasant side effects

This no-win choice is coming soon to a drugstore near you.

A year ago, I wrote about the U.S. Food and Drug Administration's consideration of over-the-counter sales for the fat-blocking drug, orlistat. It now has the FDA's blessing: Expect to see it on store shelves this summer under the name alli (pronounced "ally").

This is no magic pill, and it isn't going to work if you live on deep-fried candy bars and consider lifting the remote vigorous exercise. alli might help you shed some extra pounds - if you work out and eat a low-cal, low-fat diet along with it.

But if you're doing that, why take a pill?

Its maker, GlaxoSmithKline, says that alli might help people lose 50 percent more than they would with dieting: that means 3 pounds instead of 2, 7.5 pounds instead of 5, 15 pounds instead of 10. No guarantees, of course.

The drug works by blocking digestion of 25 percent of the fat in your food, about 150 to 200 calories a day. Over six months, people who tested the OTC version lost 4 to 6 pounds more than those who took a placebo.

Still planning to pick up a case or two? Don't forget the adult diapers.

Sad to say, but that lost poundage comes at a price, and I'm not just talking about the $1 to $2 a day it's going to cost. The drug company refers to them as "treatment effects," which is its tidy euphemism for bowels gone wild and toxic undies.

Remember, orlistat works by blocking absorption of fat. And it's gotta come out somewhere.

What the experts are saying

• Dr. David Katz, director of the Yale Prevention Research Center, commenting on the possibility of abuse of alli by the eating-disordered:

"Anal leakage is not likely to be too socially acceptable among image-conscious teens - or anyone else, for that matter."

• Dr. Alastair Wood, FDA panel chairman, to company executives during hearings on its proposed OTC status:

"Have you considered placing a warning on the box, 'Don't take this product while wearing your new La Perla underwear'?"

What is this stuff?

Here's the skinny on the fat-blocker alli (pronounced "ally")

• What: Over-the-counter version of the prescription drug Xenical (orlistat), one of a new class of anti-obesity drugs known as lipase inhibitors and the only FDA-approved weight-loss treatment.

• Who it's for: Overweight adults following an exercise program and a reduced-calorie diet with no more than 30 percent of calories from fat, preferably closer to 15 percent

• Who it's NOT for: Anyone under 18; anyone with a body-mass index less than 27 to 30; people who already have trouble absorbing food; organ transplant recipients; people on blood-thinning drugs; diabetics or people with thyroid disease

• What it does: Prevents enzymes in the gastrointestinal tract from breaking down dietary fats into smaller molecules, decreasing fat absorption by 25 to 30 percent

• Pros: Effects limited to the digestive tract. In studies, weight loss was 4 to 6 pounds more than with a placebo over six months.

• Cons: Effects can include gas with oily discharge, diarrhea, bowel urgency and anal leakage. Study participants who stopped using the drug regained all lost weight. Calorie-counting still required.

How much fat?

• To help avoid icky side effects, the drug maker recommends that alli be taken with a low-calorie, low-fat diet - ideally 15 percent of daily calories. To put that into perspective, let's say your diet plan allows 1,600 calories a day; 15 percent is 240 calories. Divide that by 9 - the number of calories in a gram of fat - and you're allowed 26.4 grams of fat per day.

Is alli your ally?

Here's GlaxoSmithKline's "alli weight-loss readiness quiz." The company estimates at least 5 million Americans a year will use alli.

• I am willing to do the hard work to lose weight gradually.

• I am committed to following a reduced-calorie, low-fat diet (an average of 15 grams of fat per meal).

• I understand that if I take alli with a meal containing too much fat, I may get bowel changes known as treatment effects.

• I am committed to eating smaller portions.

• I am committed to making time to be more physically active.

• I will read and follow the alli label.Source: Myalli.Com

alli facts

60mg dosage in each alli pill, half the strength of the prescription version Xenical.

• A, D, E & K: Water soluble vitamins whose absorption is blocked by the drug - so you need to take a multivitamin pill as well.

• The less fat you eat - say, 15 percent of total calories - the less severe the side effects, which might subside after a month or two or last much longer.

• GlaxoSmithKline already has a Web site up for future alli users (myalli.com) that will offer support and guidance, including a customized online action plan, menus and shopping lists, lessons about meal planning, managing hunger, dealing with setbacks and a way to chat with other alli users.

More expert opinions:

• Dr. Jim Hill, director of the Center for Human Nutrition at the University of Colorado Health Sciences Center:

"The bottom line is, look at what's out there for weight loss - there are some really, really scary products. This one is not very scary."

• Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, in a petition last April asking the FDA to ban orlistat:

"This drug causes a significant increase in the incidence of aberrant crypt foci, which are widely believed to be a precursor of colon cancer. The failure to ban the prescription version - or worse, to make it much more widely available by allowing OTC sales - is a decision that is likely to increase cancer incidence. Orlistat is a drug that has shown minimal efficacy coupled with both known and potentially important serious adverse events."

• Suzanne Farrell, spokeswoman for the American Dietetic Association and owner of Cherry Creek Nutrition:

"As a dietitian, I'm concerned about over-the-counter use, since diet instruction from a health professional wouldn't be something that came with it."

Comments from diet-blog.com:

• "I took this for one day. That was more than enough for me. I decided that I would rather deal with the indignity of being overweight than the indignity of soiling myself. Whoever came up with this drug hates overweight people and wants to punish them."

Carla

• "I am 5 feet 4 inches and weigh 115. (Orlistat) is great for me, and it has worked for years with very few side effects. Really. It should be something that we all use."

April

• "I was on it when I was around (198 pounds), and I got down to (130 pounds). Without the (orlistat), I was more likely to eat bad foods because there was nothing to stop me. Now I am less likely to because I don't want to spend all day on the toilet."

Vanessa

The company says

• Steven L. Burton, vice president, Weight Control, GlaxoSmithKline Consumer Healthcare, announcing alli's OTC approval earlier this month:

"With alli, we're excited to offer a revolutionary approach to weight loss. alli is more than a pill - it's a comprehensive program that works in conjunction with a sensible diet to increase weight loss. Because weight loss doesn't happen overnight, we're starting to educate consumers now about the importance of realistic expectations, gradual weight loss and lifestyle changes."

Experts advice caution on slimming pills

2007-02-24T09:57:00.001-08:00

Crores of rupees are spent on weight loss supplements, fad diets slimming pills and quick fix products, according to reports.

There are more than 300 million clinically obese and one billion overweight adults, reports say.

For the first time the Food and Drug Administration of the United States has given the go-ahead for over the counter sales of a weight loss compound Orlistat sold under the name of Alli.

It's a move that many say will go a long way in providing a comprehensive support programme for losing weight.

Alli has been approved for use along with a reduced calorie and low fat diet and promises to make people lose 50 percent of weight than diet alone.

The recommended dose is one 60 mg capsule three times a day with meals containing fat.

The drug blocks the absorption of fat in the intestine and calories from that fat. Glaxo claims that this will be a revolutionary approach to weight but here' s the catch.

"Orlistat's has no life threatening side effects but can have unpleasant side effects - oily spotting and uncontrollable bowel movement," says Professor Nikhil Tandon with the Department of Endocrinology at AIIMS.

Artificial control

In India there is a range of drugs available over the counter for weight loss.

Compounds like Sibutramine sold under the name of Obego or Obestat work by inhibiting the region of the brain that controls appetite.

They trick the body into thinking that it is not hungry but experts say they have dangerous side effects including high blood pressure and pulse rate.

There are also herbal and ayurvedic formulations.

"These are untried and untested. Manufactures come up with all sorts of exotic formulations that have never been clinically tried," says Dr Gulhati, the editor of MIMS.

"Many of them are illegal because drug laws don't permit the marketing of ayurvedic medicines without testing unless they are part of the classical text books old ancient texts on ayurveda.

Losing weight is a commitment that takes patience and discipline.
Magic short cuts may seem easy but weight loss pills are recommended only for people who are medically obese.

The treatment for obesity is not just about popping a pill but it must involve counseling, exercise and dietary changes.

New diet pill has icky side effects

2007-02-24T09:55:00.000-08:00

Local health officials and diet specialists aren't exactly praising the recent approval of a weight-loss drug once prescribed exclusively by doctors to treat overweight patients.

The Food and Drug Administration recently approved Alli (pronounced AL-eye) for over-the-counter sales. The weight-loss drug is a lesser dosage of the drug Orlistat, manufactured by GlaxoKlineSmith, and will be available this summer to people 18 and older, the first time such a pill has been obtainable without a prescription.

And with the obesity epidemic growing nationwide, some health experts say the pill could come in handy for adults looking to shed some pounds. Critics, however, point out that Alli could come at a cost to your physical well-being.

For one, pharmacist Dave Smatko, owner of the Medicine Shoppe in Beaver Falls, said there are gastrointestinal side effects that include severe diarrhea. When taken with meals, Orlistat blocks about one-quarter of any fat consumed, usually 150 to 200 calories. Unabsorbed fat leaves the body in excrement, which can be loose.

"I would hope that any pharmacist would at the very least mention the biggest, worst side effect that is associated with that drug, the whole diarrhea issue," Smatko said.

Smatko, who was actually surprised to see the diet pill approved for over-the-counter use, said the pill could also cause problems for some users depending on how it interacts with fats in their diet.

Judy Wood cringes at the idea of diet pills. As director of the Beaver-based Life Changers, a weight-loss-management center, Wood has helped people since 1985 giving seminars on how to maintain proper diet and exercise. She said the truth is there is no gimmick, only old-fashioned basics of diet and exercise.

"If you don't work at changing your habits and lifestyle, once you quit taking the drug, then what happens?" Wood asked.

Sherry Wilson, co-owner of Curves in New Brighton, said it would be wonderful if there was a pill you could take to keep off the weight. Wilson said she has never taken diet pills and worries about the long-term side effects for people who do.

"I really don't think there's ever going to be a substitute for a healthy lifestyle," Wilson said.

The 60-milligram capsule can be taken up to three times a day with each fat-containing meal, along with a multivitamin at bedtime. The diet pill reduces the absorption of fat and is meant to be used along with a reduced-calorie, low-fat diet and exercise program.

The drug is not intended for people who are not overweight or who have problems absorbing food, according to the FDA.

Some experts say by helping people to lose weight, the drug has its benefits since weight loss can lower cholesterol and blood pressure, and prevent diabetes and other conditions exacerbated by obesity.

"We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and Type 2 diabetes," Dr. Douglas Throckmorton, deputy director for the FDA's Center for Drug Evaluation and Research, said in a statement.

Abuse of the pill is also a potential problem, which would mean eating a lot of fatty foods and taking more than the recommended dosage. But distributors would have only so much oversight.

Smatko said the system will probably work similarly to the way pharmacists handle cold medicines containing ephedrine. The product would be kept in the back, out of the reach of body-conscious teenagers. In order to make a purchase, a person would have to produce identification and sign for the product, with limit restrictions on purchases as recommended by the manufacturer or statute.

Smatko said the prescription for a 30-day supply is so expensive - try $2.50 a capsule multiplied by 90 - many patients who began taking it never came back for a refill. Part of it was the side effect, but also Smatko added, "almost no insurers covered this item."

Once the drug goes on sale, he thinks the price will drop precipitously.

FDA sets new guidelines for diet-pill makers

2007-02-24T09:52:00.000-08:00

Companies should prove products help people keep off weight for a year

As more Americans struggle with growing waistlines, U.S. health officials Wednesday set out their own tips for drugmakers seeking to develop products for people trying to shed pounds.

The Food and Drug Administration’s draft guidelines — more than 10 years in the making — aim to help companies develop and test new drugs and devices for treating obesity.

About a third of U.S. adults, or more than 60 million people, are obese and another third are overweight, government statistics show. Nearly a fifth of U.S. children weigh too much.

The FDA proposed that companies should prove their products can help people lose weight and keep it off for at least a year. It also urged them to study people with a body mass index of at least 30 or those with a BMI of at least 27 who have weight-related conditions such as diabetes and heart disease.

BMI is calculated as weight in kilograms divided by height in meters. People with a score of 25 to 29.9 are considered overweight, and those at 30 or higher are considered obese.

“In general, patients should have or be at significant risk for weight-related morbidity and mortality,” the FDA said.

More room for diet products
The proposed guidelines come as more drugmakers look to enter the U.S. weight-loss sector, which some analysts have said remains untapped.

Overweight individuals are at risk for other, potentially life-threatening problems. In addition to diabetes, high-blood pressure and certain cancers are also possible.

Drugs usually aim to help people lose weight by curbing their appetite or preventing fat absorption. Some devices, such as Allergan Inc.’s Lab-Band, are used in surgical procedures to limit stomach size.

Last week, GlaxoSmithKline Plc won U.S. approval to sell an over-the-counter version of Roche AG’s prescription obesity drug Xenical, called Alli.

Sanofi-Aventis is also awaiting the FDA’s ruling on its Acomplia drug, which the agency earlier this week postponed until July.

Drugmakers often rely on guidelines
Although the guidelines are non-binding, drugmakers often rely on them when developing products. Companies may take other approaches as long as they meet legal standards, the FDA said.

They could also help prompt more manufacturers to develop weight-loss solutions.

“Given the large market opportunity, the health consequences of no therapy, we were shocked that we could only find 17 companies” with products on the market or in advanced development, Susquehanna Financial Group analysts wrote in a recent research note.

FDA officials first proposed the guidelines in 1996, but they lingered until 2004, when the FDA sought public comments.

The revised version, now on the FDA’s Web site, includes advice on products for children as well as those combining two or more drugs. It also offers guidance for products aimed at patients whose extra pounds result from other medications.

“The use of weight-management products in pediatric patients, as in adults, should be contemplated only after a sufficient trial of lifestyle modification has failed,” the FDA said.

The proposal calls for studies to include a wide variety of patients from different regions and racial backgrounds.

Diet pill: ‘alli’ or enemy?

2007-02-24T09:48:00.000-08:00

In an effort to shed even just a few pounds, some students look further than diet and exercise to find a medical way to gain their desired appearance.

At the local Westwood General Nutrition Center, which sells health supplements, vitamins and other health and diet related medications, diet pills are one of the most popular items, said Steven Nunes, an employee at the local Westwood General Nutrition Center.

But until last week, none of the diet pills that were available over the counter had been approved by the U.S. Food and Drug Administration.

The pill, called alli, has drawn both criticism and praise from experts since its increase in accessibility to the general public was approved by the FDA last week.

The pill’s approval is recommended for use by overweight adults in conjunction with a low-fat, reduced-calorie diet. It is expected to be available in stores nationwide by this summer.

And the FDA’s stamp of approval means for some students that the use of a diet pill to lose weight would not be out of the question.

Though Ben Kurtz, a third-year political science student, said he had never tried a diet before, he said if he needed to lose weight, he may turn to the newly approved pill.

“I guess if it was proven to be safe and was sold at a reasonable price ... I’d consider the diet pill,” he said.

The primary function of alli is to prevent the absorption of fats from one’s diet, thus reducing overall net daily caloric intake, according to its Web site.

Formerly, the pill was available only by prescription and was twice its current dosage.

Though alli has been approved, there are several side effects, which have caused some doctors and nutritionists to warn consumers about the pill.

While the primary side effects are gastrointestinal-related, GlaxoSmithKline Consumer Healthcare called the side effects “treatment effects,” which may be quite severe and painful.

The most common side effects are loose or oily stool and frequent and urgent bowel movements.

“If you take too much of it, it’d probably be worse than not taking the pill,” Roberts said. “Hopefully that will disallow people from abusing it.”

Sherry Rahmatian, a second-year psychology student, said she would not use the diet pill, even in its approved over-the-counter form because she is concerned about the health risks and potential side effects.

“I’ve tried to eat healthy before, to watch my diet, but I don’t think I would ever take the new diet pill, especially if I’d experience the side effects that are associated with it,” she said.

The medication works by inhibiting certain enzymes that break down triglycerides, a type of fat, in the intestine. The triglycerides are prevented from being converted into absorbable fatty acids and pass freely through the body due to the inactivity of the enzyme

The directions given from the pill’s makers state that the simple consumption of this pill will not work miracles, and it is still required that consumers exercise regularly and adjust to more healthy eating habits in order to see any form of weight loss.

GlaxoSmithKline, the company responsible for marketing alli, has said on its Web site that those who “limit fat and calories through diet, use alli capsules, and get more physically active” will lose 50 percent more weight than with diet alone.

UCLA physiological science professor Christian Roberts said the majority of weight loss will not come solely from the pill, but from a change in lifestyle that incorporates a combination of exercise and a healthy diet.

“The bulk of the weight loss will be due to the lifestyle change and not the medication,” Roberts said, citing that the dosage of the over-the-counter alli is only 60 milligrams, just half of what is prescribed normally.

Manufacturers of the pill said they are offering what they see as a new outlook on weight loss that will revolutionize how users of the drug go about their daily lives and effectively help them lose the weight they couldn’t lose by other means.

“With alli, we’re excited to offer a revolutionary approach to weight loss,” Steven L. Burton, vice president of weight control at GSK, said in a statement. “Alli is more than a pill — it’s a comprehensive program that works in conjunction with a sensible diet to increase weight loss. Because weight loss doesn’t happen overnight, we’re starting to educate consumers now about the importance of realistic expectations, gradual weight loss and lifestyle changes.”

The growing problem then becomes the actual desire for users to adapt and remain dedicated to the new lifestyle that is required for the successful implementation of alli. Roberts said users of alli looking to lose between 20 and 30 pounds will likely be disappointed due to the amount of time required to do so.

Several studies have been conducted that show that once the use of alli is stopped, participants regained much of their weight that they had initially lost.

Roberts said alli should be used only after one has been thoroughly assessed by either a dietician or nutritionist, and even then, it should be very well understood that it takes more than the simple popping of a pill to lose the weight and serious lifestyle changes must be made.

“I wouldn’t recommend it initially,” Roberts said. “I would assess, first of all, what is the person trying to do? What is the goal? How much weight loss are they trying to achieve? Have they tried to change eating habits and exercise patterns?”

And after having answered all those questions, one could find several other more effective means of losing weight at a similar pace and in a more effective manner, Roberts said.

“The effects are going to be small, and to be honest, there are other diet pills on the market that I think are more effective,” Roberts said. “I would start with just changing lifestyle and going from there.”

FDA approves first OTC weight loss pill

2007-02-14T08:57:00.000-08:00

The Food and Drug Administration (FDA) approved an over-the-counter version of the fat-blocking diet drug Xenical last week, making it the first FDA approved weight loss product available without a prescription.

The drug will be sold under the brand name Alli and will contain about half the amount of the fat-blocking drug orlistat than the prescription version contains.

GlaxoSmithKline, the company that manufacturers the pill, expects the drug to be in stores by summer 2007.

Alli blocks the absorption of about 25 percent of the fat consumed when taken at meal times. The fat is then passed out of the body through stools and eliminates about 150 to 200 calories from fat.

Consuming a high-fat meal while using Alli can result in uncomfortable bowel changes such as loose stools or a sudden urge to use the bathroom, Brian Jones, vice president of communications for GlaxoSmithKline.

According to a press release, the recommended dose is one 60-milligram capsule, three times a day, with meals.

"It is about 60 cents a capsule," Jones said. "It is certainly affordable for most Americans. It's about the cost of a soda and a bag of chips."

The drug is intended for people 18 and older and because of the way it works, the company recommends that it be used in combination with a healthy lifestyle, exercise, and a reduced-calorie diet that contains about 15 grams of fat per meal.

"Essentially, you have to follow a low-calorie diet to be successful," Jones said. "It's not a magic pill that will cause you to lose weight in hours."

Users will lose weight steadily over time, Jones said.

Associate professor of nutritional neuroscience Rebecca Corwin said she is not an advocate of using drugs as a long-term solution for weight loss.

"I think they're okay in moderation," Corwin said. "The critical thing is that people have got to learn healthy habits if they're going to be successful in the long-term. That's the tough part."

Corwin said diet drugs work in two ways, reducing fat absorption and causing users to change their eating habits to reduce side effects.

"They reduce fat absorption in the [gastrointestinal] tract and reduce the actual amount of fat your body gets by about 30 percent," Corwin said.

"Also, if people break the diet and eat a lot of fat, they feel really uncomfortable," she said.

Users are also urged to take a multivitamin once daily because Alli has the possibility of reducing the absorption of certain nutrients, Jones said.

Corwin said she thinks taking a multivitamin could be helpful because of the vitamins that may be prevented from absorption.

"It's probably going to be the fat-soluble vitamins A, D, E and K," Corwin said. "It certainly won't hurt to take a multivitamin. Just make sure that it's no more than 100 percent of the recommended daily allowance."

Leslie Archard (sophomore-marketing) said she thinks people will take such diet drugs even though they are aware of the potentially unpleasant side effects that may happen as a result of taking the drugs.

"People are so insecure that they'll do it anyway," Archard said. "There's a strong drive to be considered attractive and they are making money off of people's insecurities."

About 31 percent of American adults, or 60 million people in the United States meet the criteria for obesity, according to the Centers for Disease Control and Prevention. About 65 percent of American adults are considered overweight.

"About two-thirds of American adults are overweight or obese," Jones said. "We need help. Maybe this is one of the things that can help us."

Why alli is different from other diet pills?

2007-02-14T08:46:00.000-08:00

Unlike other products on store shelves, alli is a proven medicine with a comprehensive support program. To help consumers get off to a successful start, the alli package will include Welcome and Companion Guides, a Guide to Healthy Eating, a Daily Journal, a Calorie and Fat Counter, Quick Fact Cards, and free access to an individualized online action plan at http://www.myalli.com.

"With alli , we're excited to offer a revolutionary approach to weight loss," says Steven L. Burton, Vice President, Weight Control, GlaxoSmithKline Consumer Healthcare. " alli is more than a pill - it's a comprehensive program that works in conjunction with a sensible diet to increase weight loss. Because weight loss doesn't happen overnight, we're starting to educate consumers now about the importance of realistic expectations, gradual weight loss and lifestyle changes. That's the way to see results, and with alli , we know they can do it."

Starting today, GSK Consumer Healthcare will gear up production to have the product ready for shipment and in stores by the summer. The company is using this period to build awareness and understanding about the product and its intended user �" with the message �" alli is not for everyone. It's for the committed consumer who can follow a reduced-calorie, low-fat diet. For this consumer, alli will provide a unique, proven approach to weight loss, offering straight talk, educational tools and an online support program �" myalli.com.

GSK - alli: learn from the mistakes of others

2007-02-14T08:43:00.000-08:00

Advertising prescription medicines direct to consumers is illegal in Australia, so one side benefit for pharmaceutical companies of having a drug reclassified from "prescription only" to "pharmacist only" or "pharmacy medicine" is that the drug can then be advertised, potentially expanding its market.

This happened to the weight loss drug Xenical (aka olistat aka "alli"), initially available only on prescription, which in 2004 was rescheduled as a "pharmacist only" drug and in 2006 given limited advertising approval.

However, this may be short-lived.

The classification of Xenical will be re-considered next week after complaints from consumer groups and the general public that it was being promoted as a weight loss solution to people for whom the drug is not recommended, including young people under 18 where the safety of Xenical has not been established.

These complaints focussed on the advertising of Xenical during television programs targeting young people. The advertisements have now been withdrawn after they were found to breach the advertising code for medicines. But not before they were seen by the estimated 1.3 million viewers of the popular Australian Idol program, including many who were aged under 18.

FDA approves first over-the-counter diet pill, Alli

2007-02-12T09:23:00.000-08:00

The Food and Drug Administration (FDA) has approved its first over-the-counter diet pill on Feb. 8. drug goes by the brand name "Alli" and is produced by pharmaceutical company GlaxoSmithKline. "Alli" contains half the dose of the prescription diet drug, "Xenical".

Doctors say the pill, to be taken before each meal containing fat, works by not allowing the user's gut to digest consumed fat. "Alli" works by blocking the absorption of roughly 200 calories of fat from each meal. Undigested fat is removed in the stool.

However, there are gastrointestinal side effects to the pill such as diarrhea. Patients can expect to lose between six to 10 pounds during the course of six months to a year.

Dr. Adi Mehta, weight loss expert at Cleveland Clinic said, "This medication works in the gut. Basically what it does is not allow the gut to digest the fat that you take in. If you digest it, you can't absorb it. If you can't absorb it, therefore it can't go in to the wrong place in your body."

F-D-A researchers say the drug is for people 18 and older and say it should be used in combination with a diet and exercise program.

Talking about gastrointestinal problems, Dr. Mehta says these can help people lose weight.

"The beauty of this medication is because you don't want to have the oily stool and the discomfort from it, you tend to start to restrict how much fat you take in. And by doing that, you're sticking to a diet and to that extent, you're going to get enhanced ability to lose weight."

'Alli' is not for people who've had organ transplants. And people taking medicine for high blood pressure and diabetes should talk to their doctor before using the drug.

The new diet pill, estimated to cost below two dollars, is expected be on store shelves beginning this summer.

Alli: FDA approves first over-the-counter weight-loss drug

2007-02-12T09:18:00.000-08:00

Overweight adults who are struggling to shed excess pounds have a new over-the-counter (OTC) weapon in the fight against obesity.

The weight-loss drug orlistat (Xenical) was originally approved in 1999 as a prescription drug to treat obesity. Now, the Food and Drug Administration has approved a reduced-strength OTC version of orlistat (Alli) for adults age 18 and older.

Alli promotes weight loss by decreasing absorption of fat by the intestines. The capsules are taken with meals, up to three times a day. It sounds like a dieter's dream, but there are no shortcuts to permanent weight loss. Alli is intended to be used only with a reduced-calorie, low-fat diet and regular exercise.

The most common side effects of Alli include diarrhea and gas with oily spotting. These and other bowel changes can be minimized by eating a low-fat diet. A daily multivitamin is recommended to offset the loss of fat-soluble nutrients, such as vitamins A, D and E.

Alli shouldn't be taken by anyone who has a healthy weight, who's taking cyclosporine, who's had an organ transplant, or who has problems absorbing food. The drug also may pose risks for anyone who takes blood-thinning medication or has diabetes or thyroid disease. Some studies have associated the prescription-strength version of the drug with precancerous changes in the colon.

Alli is expected to be available by summer 2007.

What does this mean to you? If you're struggling to lose excess weight or you have medical complications of obesity, an OTC weight-loss drug may be an appealing option. Remember, however, weight-loss drugs aren't a silver bullet for weight loss. And they aren't a good choice for everyone who's overweight.

It's best to lose weight through a healthy diet and regular exercise. But if you're already following a reduced-calorie, low-fat diet and exercising regularly, Alli may help you lose additional pounds. Work with your health care provider to evaluate the potential benefits and risks of Alli or any other weight-loss drugs. As a team, you can create the most effective weight-loss plan for you.