FDA Advisory Panel Rejects Weight-Loss Drug

Jamie Sheller
Attorney
(866) 735-1102 Ext 475
Posted by Jamie ShellerJune 27, 2007 6:05 PM

The weight-loss drug rimonabant or Zimulti, made by Sanofi-Adventis, has hit a stumbling block in seeking to enter the market. An FDA advisory panel has unanimously voted to reject the drug. Though rimonabant is sold in 18 other countries, the panel found that Sanofi-Adventis had failed to prove the safety of the drug, though it was shown to be effective in weight loss. In studies, twice as many psychiatric side effects were reported with use of rimonabant, compared to those receiving a sham treatment. The reported psychiatric events included depression, suicidal thoughts, sleep problems and anxiety. Usually, the FDA follows recommendations by the advisory panels, but it is not required to do so. A final decision by the FDA is expected by July 27.

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