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Regulators at the Food and Drug Administration are concerned that a proposed weight-loss drug by Sanofi-Aventis called Acomplia may carry a significant risk of triggering suicidal thoughts, according to documents released Monday. In briefing documents released on the company's website, FDA reviewers noted that while Acomplia did appear effective in significantly lowering weight, users also had a higher incidence in certain suicidal behavior. The documents were released ahead of an advisory panel meeting on the drug's market application, which is scheduled for Wednesday. While the agency is not bound to the recommendations of its advisory panels, it often follows them. Acomplia , also known as rimonabant, was approved in Europe for weight loss in June 2006. However, the FDA has been leery of approving the drug over concerns that it can spark depression or suicidal thinking in some users. French drugmaker Sanofi (SNY) first submitted its application for U.S. approval in April 2005. In February 2006, the FDA ruled it needed additional information on the drug's psychiatric side effects before it could consider approving it. Sanofi submitted the information in October 2006. A final decision on Acomplia is expected by the end of July. Source: http://money.cnn.com/ ;
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