Sanofi-Aventis' Acomplia weight-loss pill may raise the risk of suicide and suicidal thoughts, U.S. regulators said in documents posted two days before an expert panel meets to recommend whether the drug should be approved.
Twenty milligrams, the highest dose, resulted in statistically and clinically significant weight loss, the Food and Drug Administration's staff said in documents posted today on the agency's Web site. An agency advisory panel will meet June 13 to discuss whether the medicine's benefits of reducing weight, cholesterol and blood sugar outweigh its risks.
Acomplia, to be sold as Zimulti in the U.S. if approved. The agency will issue a decision by late July. Analysts say the FDA, which has delayed approval of the drug three times, may be wary about Acomplia's side effects.
The agency has come under pressure in recent weeks after a study showed a diabetes drug approved in 1999, GlaxoSmithKline Plc's Avandia, raised the risk of heart attacks.
Some patients who took part in clinical trials of Acomplia suffered from mood swings, anxiety and depression.
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