By a unanimous vote, a panel of experts convened by the FDA just rejected Sanofi-Aventis's weight-loss drug, known in Europe as Acomplia, Dow Jones reports.Of course, the FDA could approve the drug application anyway since these advisory board decisions are non-binding. Although I don't think this is likely, keep in mind that the FDA considers the drug safety measures pending in the House of Representatives as a "burden," for regulators (see "FDA objects to parts of House drug safety plan").
The drug has been associated with psychiatric side effects including depression and an increased risk of suicidal thoughts. In a presentation to the panel today, Sanofi officials argued that patients at risk of psychiatric problems could be screened to not receive the drug. The drug has been approved for sale in Europe, but has not been approved here due to concerns over its side effects.
Wednesday, June 13, 2007
FDA: Zimulti Non-Acomplia!
As reported in the Wall Street Journal Health Blog, an FDA advisory panel unanimously rejected Zimulti: