Federal Panel Rejects Weight Loss Drug

A panel of federal health advisers has voted unanimously to reject weight loss drug rimonabant, after hearing testimony on the drug's safety. The U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee concluded that French manufacturer Sanofi-Aventis SA failed to prove that the weight loss drug was safe, especially in light of evidence linking rimonabant use to psychiatric effects including depression and suicidal thoughts. The panel serves the FDA in an advisory capacity, but its conclusions carry great weight in the FDA's approval process. The FDA is set to decide on approval of rimonabant (under the brand name Zimulti) by July 27.

• FDA Briefing Document on Zimulti (rimonabant) [PDF file]
• Sanofi-Aventis Press Release [PDF file]
• AP News: U.S. Federal Panel Rejects Sanofi-Aventis Weight-Loss Drug
• Defective and Dangerous Products (FindLaw)