FDA Approves OTC Diet Pill
Side Effects Include Loose Stools, Flatulence
POSTED: 7:36 am EST February 8,
2007
UPDATED: 8:48 am EST February 8,
2007
NEWTON, Mass. -- The real deal or a red herring? The U.S. Food and Drug Administration has approved a fat-blocking diet pill for over the counter sales, but is it the quick fix so many are hoping for?NewsCenter 5's Gail Huff reported that there are many drinks, shakes and pills on the market that are supposed to help people lose weight, but none of them are approved by the FDA.This is the first time the FDA has approved a non-prescription diet pill. Xenical, also known as orlistat, is currently available only by prescription, but this summer the same drug will be available in half the dose over the counter. The over-the-counter name is alli. Xenical, the prescription version, is made by Roche Holding AG."The people probably will definitely be coming in here asking for it," said pharmacist Michael DeRosa. "It didn't do very well as a prescription product because of the high cost."The new OTC diet pills will be cheaper than Xenical. When taken with meals, the drug blocks about one-quarter of fat consumed. The drug is intended for people 18 and older to use along with a reduced-calorie, low-fat diet and exercise. About 150 to 200 calories are passed outside of the body with some unattractive side effects."Some of the more common side effects are oily stools, actually spotting, flatulence, nothing that's very pleasurable," DeRosa said.But for some potential consumers, that's not enough to dissuade them."Sounds good to me. Anything that goes out the other end sounds very good to me," one customer said.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 drug has its detractors. The Public Citizens Health Research Group called the FDA approval "the height of recklessness," and said studies have associated the higher-dosed Orlistat with pre-cancerous lesions of the colon.GlaxoSmithKline PLC is the company that manufactures the drug. They said that 28 percent of the people who took the drug lost 5 to 10 percent of their body weight.
Copyright 2007 by TheBostonChannel.com. The Associated Press contributed to this report. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.






