Side effects of Alli, cost worth considering

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

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

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.