The FDA said Monday that Sanofi-Aventis’ weight-loss drug Acomplia (rimonabant) may trigger suicidal behavior and other psychological side effects in some patients.
The agency posted its a review of the drug online ahead of a Wednesday meeting which outside experts are expected to vote on whether rimonabant should be approved.
Although the FDA does not have to follow the advice of its outside expert panels, it often does.
The FDA is scheduled to issue a final decision on the drug July 27.
Clinical studies from the drug’s maker show that patients taking rimonabant displayed significant weight loss after two years. However agency staffers raised concerns about an increased rated of psychiatric adverse events among patients taking rimonabant including depression, anxiety and insomnia.
The FDA noted a possible link between rimonabant and suicidal behavior.
In studies of the drug, Sanofi-Aventis reported one patient committing suicide and eight patients with suicidal thoughts. Among patients taking a placebo, Sanofi-Avnentis reported two suicide attempts and five cases of suicidal thoughts.
Shares of Sanofi-Aventis fell 19 cents to $45.31 in early trading on Monday.
Rimonabant is considered a potential blockbuster despite hitting multiple regulatory
bumps that have left Wall Street analysts questioning the drug’s future.
“With the initial demand for Acomplia (rimonabant) likely to be massive, the known neuropsychiatric side effects may make it difficult for the FDA to see a positive risk-benefit ratio,” wrote Citigroup analyst Kevin Wilson.
According to Wilson, the FDA review of the drug will likely focus more on safety than effectiveness and drive Sanofi-Aventis’ stock price down.
Sanofi-Aventis originally touted rimonabant as an anti-obesity and anti-smoking treatment because it stops cravings associated with addictive behavior.
Last February, the FDA rejected Sanofi-Aventis’ application for the anti-smoking use and said it needed more information before approving the drug to fight obesity.
If rimonabant is approved in the US, Sanofi-Aventis said it would market the drug under the drug name Zimulti, because FDA reviewers felt its previously proposed brand name of Acomplia could be misleading to consumers.