FDA panel unanimously rejects new diet pill

Federal health advisers unanimously rejected a weight-loss drug after hearing testimony that it increases the risk of suicidal thoughts.

The manufacturer, Sanofi-Aventis SA, failed to show the drug rimonabant is safe, the panel said.
The unanimous finding by the expert panel’s 14 voting members made it unlikely the Food and Drug Administration will approve the drug. The agency usually follows its panel’s advice, but it isn’t required to do so.

“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 Dr. Jules Hirsch, of The Rockfeller University.

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 sham treatment, Dr. Amy Egan, a FDA medical officer told federal health advisers. “The numbers of events are small, but in aggregate they are worrisome,” Egan said.

Officials from Sanofi-Aventis SA, the manufacturer of the drug, suggested that patients be screened for depression before they are prescribed the drug. They also advised that patients visit their doctors five times during the first year of treatment to be reassessed to curtail any potential problems.

The FDA is to make a final decision on the drug by July 27.