UF experts urge caution with diet pill called Alli

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

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?

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

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?

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.