FDA Advisory Panel Rejects Weight-Loss Drug

Possible side effects send Acomplia to the sidelines
By M. Morris,  Newser Staff
Posted Jun 14, 2007 6:41 AM CDT
Food and Drug Administration Commissioner Andrew von Eschenbach, center, flanked by Gerald J. Dal Pan, director of the Office of Drug Safety at the FDA, left, and Dr. John Jenkins, director, Office of...   (Associated Press)
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(Newser) – Accomplia, a weight-loss drug marketed in 18 other countries, failed to win approval from an FDA advisory board yesterday. The 14-member panel of outside experts ruled unanimously that manufacturer Sanofi-Aventis had not dispelled concerns about the safety of the drug, whose potential side effects include suicidal thoughts, anxiety, and depression.

The recommendation is not binding, but the FDA usually follows its review boards' advice. Acomplia, which is marketed in 18 other countries, blocks food-craving receptors in the brain. It will be called Zimulti in the US should it clear regulatory hurdles. Having already deferred a decision on Acomplia three times, the FDA is expected to act by July 26.