FDA Shouldn't Approve Rimonabant, Panel Says
Concern about suicidal thoughts cited by agency advisers
THURSDAY, June 14 (HealthDay News) -- The weight-loss drug rimonabant should not be approved by the U.S. Food and Drug Administration because of continuing concerns about increased risks for suicidal thoughts among some users, an advisory panel concluded Wednesday.
The unanimous 14-0 vote followed another unanimous vote by the panel that drugmaker Sanofi-Aventis had failed to prove the safety of its drug, the Associated Press reported.
"There is a reasonable suspicion we better learn some more and watch this affair more closely before we launch into massive use of this drug," said panelist Jules Hirsch, M.D., of The Rockefeller University.
While the FDA isn't bound to follow the recommendations of its advisory panels, it typically does.
Rimonabant has been touted by Sanofi-Aventis as a drug that aids in weight loss and also helps people stop smoking, but the drug has been linked to increased risk of suicidal thoughts among some people who take it.
The consumer advocacy group Public Citizen said it remains opposed to the drug's approval.
The FDA is expected to decide by July 27 whether the drug should be on the market. If approved, the drug would be sold in the United States under the name Zimulti. In Europe, it is sold under the brand name Acomplia.
Last year, the FDA decided not to approve rimonabant as an aid to stop smoking.