It’s as if they’re playing hokey-pokey over at the FDA.
The Endocrinologic and Metabolic Drugs Advisory Committee recently gave a thumbs-up to Qnexa fewer than two years after recommending against it. It’s the first time since 1999 that an advisory panel for the federal agency has approved a weight-loss drug.
The FDA doesn’t have to accept the panel’s advice, but usually does.
The side effects that prompted the initial rejection of Qnexa are still of concern, but experts believe that if the drug is used only by a certain segment of the obese population and if trials study its performance after approval, the benefits for that population supersede the risks. ??Like all the expansive media coverage of the Qnexa announcement, MedPage Today reported that concern centers around the increased risk of an elevated heart rate and of birth defects, specifically oral clefts.
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