Sanofi Drug Has Suicide Risk

Although an experimental drug from Sanofi-Aventis (SNY) effectively reduces weight, it also increases the risk of psychiatric problems, including suicidal thoughts and behavior, a government report said Monday.

Compared to a placebo, a recommended dose of the drug "statistically significantly increased" suicidal thinking and actions, says the staff of the Food and Drug Administration. The staff issued its analysis two days before a committee of outside medical advisers reviews the drug, which is sold as Acomplia in foreign markets and is now called Zimulti in the U.S.

The drug is sold in at least 10 countries, primarily in Europe, and it has been a source of controversy and regulatory delay in the U.S. Many analysts have predicted that Zimulti could be a multibillion-dollar product worldwide, assuming it gets approved in the U.S., which would be its biggest market.

The FDA staff report's findings helped push down Sanofi-Aventis' stock by 38 cents to $45.12 in heavy trading.

FDA staff reports are routinely issued before advisory committee meetings are held, offering analyses and suggesting questions for panel members. The advisors make recommendations, and even though the FDA isn't bound by the panels' votes, it usually follows them.

Sanofi-Aventis originally sought FDA approval in April 2005 for the drug to treat obesity and help smokers quit. The latter application was rejected, and the weight-loss application was granted conditional approval in February 2006. Sanofi-Aventis refiled its weight-loss application in October. But the drug has experienced subsequent regulatory delays.

The FDA's conditional approval was based primarily on concern about "increased frequencies of psychiatric events, including suicidality," says the FDA staff report, which was posted on the agency's Web site.