WASHINGTON — Federal health advisors unanimously rejected a weight-loss drug Wednesday after hearing testimony that it increases the risk of suicidal thoughts, even in patients without a history of depression.
The manufacturer, Sanofi-Aventis, further failed to show that the drug rimonabant is safe, the panel said.
Two 14-0 votes by the expert panel made it unlikely that the Food and Drug Administration would approve the drug. The agency usually follows its panel's advice, but it isn't required to do so.
In studies, patients given the once-daily tablet reported twice as many psychiatric side effects, including depression, anxiety and sleep problems, than those who received placebos, Dr. Amy Egan, an FDA medical officer, told the advisors.
Officials from Sanofi-Aventis suggested that patients be screened for depression before they are prescribed the drug.
The FDA is to make a final decision on the drug by July 27.