FDA panel rejects Sanofi-Aventis' Acomplia drug - MarketWatch

Another potentially promising drug, rimonabant, bites the dust.

FDA panel rejects Sanofi-Aventis' Acomplia drug - MarketWatch

In a report prepared by the panel and published Wednesday, concerns were raised about the safety of Acomplia, particularly its effect on users' mental health. Sanofi-Aventis submitted data and analyses on Acomplia for the panel's review late last year.

"Adverse events" encountered during the testing of the drug included "depressive events, anxiety, psychomotor agitation, and sleep disorders," according to the panel's report.

The FDA's Division of Metabolism and Endocrine Products has received a number of "event" reports from Sanofi-Aventis related to Acomplia, the report said, including "4 reports of delusional symptoms, 6 reports of psychotic behavior (including a man who attempted to strangle his daughter), and 5 reports of aggression (including a man who beat his wife.)"

Rimonabant, the generic form of Acomplia, is approved in 37 countries and marketed in 18, according to Sanofi-Aventis.