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FDA approves sale of first over counter fat blocker

By ASSOCIATED PRESS
Published February 8, 2007

WASHINGTON - 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.

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.

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

In trials, for every 5 pounds people lost through diet and exercise, those using orlistat lost an additional 2 to 3 pounds,Ganley said.

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.

Fast Facts:

A new diet weapon

What is it? A lower-strength version of the weight-loss pill orlistat, which will be sold as "alli." It will be the first FDA-approved over the counter diet pill

What does it do? When taken with meals, the medication blocks the absorption of about one-quarter of any fat consumed.

What will it cost? Estimates are $1 to $2 a day

[Last modified February 8, 2007, 00:33:54]