Washington – Federal health advisers unanimously rejected a weight-loss drug Wed nes day after hearing testimony that it increases the risk of suicidal thoughts, even in patients without a history of depression.
Manufacturer Sanofi-Aventis SA further failed to show that rimonabant is safe, the panel said.
The expert panel’s back-to- back, 14-0 votes made it unlikely the Food and Drug Administration will approve the drug.
“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 New York’s Rockefeller University.
In studies, patients given the once-a-day tablet reported twice as many psychiatric side effects, including depression, anxiety and sleep problems, than those who received sham treatment, said Dr. Amy Egan, an FDA medical officer.
