WASHINGTON, Feb. 7, 2007
First Over-The-Counter Diet Pill Gets OK
FDA Approves Nonprescription Sales Of Fat-Blocking Pill Orlistat
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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.
© MMVII, 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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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.
Note a few of these quotes -
"it won%u2019t be easy, nothing worth it ever is." from the homepage. They realize that it takes hardwork to lose weight, this product is a partner and not just a cure-all. You have to do your part and the pill will help with losing more weight.
They are even more honest on the "What is alli?" page -
"First, alli is not a miracle pill or a quick fix. Lots of other weight loss products promise results overnight. But alli is based on good things like hard work, smart choices, and gradual weight loss. Second, alli is a unique combination of a pill and a plan to help you lose even more weight than dieting alone. If you could lose 10 pounds through dieting alone, you could lose 15 with alli.
But alli only works if you work. And individual results may vary."
Is is worth losing 5 more pounds? Maybe for some.
The images in my head will not stop.
A whole new meaning to %u201Cgotta go gotta go gotta go%u201D
I wonder if GSK owns a toilet paper or adult diaper co. Talk about creating a demand for your product.
Thousands of people running for the toilet, better build more rest stops on the highways
I%u2019m sorry no more potty humor
"About half of patients in trials experienced gastrointestinal side effects."
What might the common name for that be?
I%u2019m sorry folks but I can%u2019t help my self, here goes the first pun.
Alli-oops.
- by reel-crazy February 7, 2007 8:58 PM EST
- The only reason this got FDA approval was because of a powerhouse company like GSK getting it rammed through the system.
- Reply to this comment
See all 14 CommentsCel-Sci (CVM) has an anti-cancer drug that will continue to be placed on the back burners and require more lengthy clinical trials unless a company like Pfizer, GSK, Merck, King, or Astra Zeneca gets a hold of them.
What's more important here...a diet pill or a cancer cure?