CBS/AP/ September 17, 2010, 11:21 AM

First Over-The-Counter Diet Pill Gets OK

Dieters got a new tool Wednesday to help them take off the extra pounds — the first government-approved nonprescription diet pill.

The Food and Drug Administration said the fat-blocking weight-loss pill orlistat, which has been available by prescription, can be sold in a reduced-strength version over the counter.

The new version will be sold as "alli" by GlaxoSmithKline PLC. Xenical, the prescription version, is made by Roche Holding AG.

GlaxoSmithKline chose the name "alli" because it's supposed to be "allied" with a weight-loss program, including exercise and healthy eating, reports CBS News correspondent Dan Raviv.

The drug is intended for people 18 and older to use along with a reduced-calorie, low-fat diet and exercise.

Dr. Charles Ganley, FDA's director of nonprescription products, stressed that the drug is intended for use along with diet and exercise programs.

"Using this drug alone is unlikely to be beneficial," Ganley said at a telebriefing.

While some dietary supplements make weight-loss claims, Ganley said this is the first nonprescription drug approved by the agency for that purpose.

Ganley said in trials, for every five pounds people lost through diet and exercise, those using orlistat lost an additional two to three pounds.

When taken with meals, orlistat 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 in stools, which can be loose as a result. About half of patients in trials experienced gastrointestinal side effects.

The agency recommended users take a multivitamin when using this drug.

The new drug would contain half the dose of Xenical prescription capsules. The price has not been set but is expected to run $1 to $2 a day, company officials said. The company estimated 5 million to 6 million Americans a year would buy the drug over the counter.

The Food and Drug Administration said the most common side effect of the product is a change in bowel habits including loose stool and some oily spotting. Eating a low-fat diet will reduce the likelihood of this side effect.

FDA said people who have had organ transplants should not take OTC orlistat because of possible drug interactions. In addition, anyone taking blood-thinning medicines or being treated for diabetes or thyroid disease should consult a physician before using orlistat, the agency said.

GSK Consumer Healthcare, which will market the pill, said it chose the name alli to indicate a partnership with consumers in their weight-loss efforts.

"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 the FDA's Center for Drug Evaluation and Research.

"OTC orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health," he said.

But Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, called the approval "the height of recklessness." Wolfe said studies have associated the prescription version of the drug with precancerous lesions of the colon. He has also called for withdrawal of the prescription version.

© 2010 CBS Interactive Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.
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18 Comments Add a Comment
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Desireeli says:
A health supplement business has been ordered to recall its line of dietary supplements from store shelves in nine states for promoting its products as medications. Multi-Mex Distributors, Inc., was accused of selling Amoxilina as an antibiotic. The dietary supplement is packaged to look just like an over-the-counter antibiotic in Mexico, which is allegedly to trick Latino consumers into purchasing the pills. I found this here: <a title="Tablet maker forced to stop labeling diet pills like antibiotics" href="http://www.newsytype.com/6121-diet-pills-antibiotics/">Pill maker ordered to stop marketing diet pills as antibiotics: read on newsytype.com</a>
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FatDoctor says:
Awe yes, I remember the days of alli, where people had the runs and they didn't care because they lost weight.
I love how this article says that people who are over weight can get diabetes and have heart problems.... RIIIGGHHTTT.
It wouldn't be because people eat crap and then end up getting these problems. It couldn't be that our society eats too much bread and thus ends up having heart and diabetes problems. Its just because we are all fat that we have the problem, so lets give people a pill so that they can keep there diet and still get heart problems and diabetes but not be FAT.
http://www.worldclassnutrition.com/
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svetlenababovic says:
Some people swear by them, and others say that you should avoid them
and try to get your nutrition and " weight loss": http://bestdietpillssite.com mostly through mostly diet and exercise. I guess that sometimes they can help in the short term, though, as long as you research the supplement well before taking it.
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jorgjacson says:
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sy2502 says:
I have a friend who used the prescription version of this pill, and heard the horror stories about what the article politely calls &quot;gastrointestinal side effects&quot;. What it boils dows it that 150 to 200 calories in each meal get passed by your bowels instead of being absorbed by the body. How about just cutting the size of your meal by 150 or 200 calories, and avoiding the side effects altogether?
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drinuk says:
Do not believe anything Big Pharma tells you, this is yet one more get rich quick pill for them !! You stay fat with side effects they get fatter and laugh all the way to the bank with the FDA waiting in line for their handout too, they are as crooked as a two dollar note.
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lonestartnow says:
If people changed their behavior to begin with they wouldn't need a &quot;magic diet pill.&quot; Healthy nutritional choices, finding ways to become more physically active (even if you don't go to a gym) and reducing your saturated fats, trans fats, sugar and intake of refined carbs will result in weight loss--and a healthy lifestyle. Add finding ways to put your body in motion, and you're on the way to long-term success--without the supplements and expense of supplements.

How many people are looking for a magic pill because they don't do this to begin with? This is just one more example. Don't people realize taking weight loss supplements isn't the same thing as making healthy choices? It's exactly the opposite, and considering the side effects, makes no sense at all for the consumer. For the drug company, that's a different story.
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legendary240 says:
Neat! This one won't give you a heart attack. It will just turn your colon into a lead pipe and then all the calories just flow right through. Of course it will turn your eyes pink and make you hair white, but that beats walking, exercizing and eating healthy. The miracles of science never cease!
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jetlizhan says:
to really lose weight, you just have to eat healthy, stay away from fast foods, and like it or not you MUST exercise -IF YOU DON'T MOVE IT, YOU WON'T LOSE IT!!!!!!
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