Jan 23, 2006 11:05 pm US/Central
FDA Panel Approves OTC Weight-Loss Pill
WASHINGTON (AP) ―
A Food and Drug Administration panel of doctors and scientists voted Monday to recommend that the regulatory agency approve over-the-counter sales of a weight-loss pill now sold only with a prescription.
GlaxoSmithKline Consumer Healthcare still needs final FDA approval before it can sell the nonprescription version of orlistat, a drug already marketed in prescription form as Xenical, to overweight adults as use as a weight-loss aid. The FDA approved the prescription version of the fat-blocking pill made by Roche in 1999.
A joint FDA advisory committee voted 11-3 to recommend approval late Monday following a daylong hearing. The agency usually follows the recommendations of its outside panels of experts. Currently, the FDA has not approved any nonprescription weight-loss drugs for sale.
In six-month clinical trials, obese people who took orlistat lost on average 5.3 pounds to 6.2 pounds more than did those who were given dummy pills. Glaxo wants people to use it for only six months at a time, but as an over-the-counter item, its use could not be policed.
However, the pill's effect ends once its use is stopped, said Dr. Julie Golden, a medical officer in the FDA's division of metabolism and endocrinology products. A previous study showed a progressive weight gain in patients after they discontinued use of orlistat, Golden said.
(© 2006 The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.)
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