Panel Supports Offering Diet Pill Orlistat Over the Counter
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Tuesday, January 24, 2006
A panel of doctors and scientists recommended yesterday that the Food and Drug Administration approve over-the-counter sales of a weight-loss pill orlistat, marketed in prescription form as Xenical.
GlaxoSmithKline Consumer Healthcare still needs final FDA approval. The FDA approved the prescription version of the fat-blocking pill in 1999.
The advisory committee voted 11 to 2 to recommend approval after a day-long hearing. The agency usually follows the recommendations of its expert panels.
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.
But the pill's effect ends once its use is stopped, said Julie Golden, a medical officer in the FDA's division of metabolism and endocrinology products. A previous study showed progressive weight gain in patients after they discontinued use of orlistat, Golden said.
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