Thursday, June 14, 2007

Key US drug panel rejects Sanofi's obesity pill

A US Food and Drug Administration panel of experts concluded Wednesday that pharmaceutical giant Sanofi-Aventis's obesity treatment Acomplia was unsafe and should not be sold in the United States.

The 14 doctors on the advisory committee voted unanimously against allowing the French company's diet drug to go on the US market, said FDA spokeswoman Sandy Walsh.

It was also a "unanimous 14 no vote about the safety of the drug," she said.

The FDA, which is not obligated to follow the panel's recommendations but usually does, is expected to issue a decision in July.

The anti-obesity drug, which Sanofi-Aventis plans to sell in the United States under the brand name Zimulti, has been approved in the European Union.

But during the FDA advisory committee hearing, several experts indicated that the drug was linked to an increase in suicidal thoughts among patients without a history of depression.

source : news.yahoo.com

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