Eating disorders patients are likely to abuse Alli

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

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

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?

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

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

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

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

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

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

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

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

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 … 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