Panel Urges FDA Not to Approve Weight-Loss Drug

An advisory panel of experts recommended unanimously yesterday that the Food and Drug Administration reject a new weight-loss drug after hearing testimony that it increases the risk of suicidal behavior.

The manufacturer, Sanofi-Aventis, failed to show that the drug rimonabant is safe, the panel said.

The unanimous finding by the panel's 14 voting members makes it unlikely that the FDA will approve the drug. The agency usually follows its panels' advice but is not required to do so. The agency is set to make a final decision by July 27.

"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 of Rockefeller University in New York.

In studies, patients given the once-daily tablet reported twice as many psychiatric side effects -- such as depression, anxiety and sleep problems -- as those who received dummy pills, Amy Egan, an FDA medical officer, told federal health advisers. "The numbers of events are small, but in aggregate they are worrisome," she said.

Officials from Sanofi-Aventis, the Paris-based 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 for an assessment five times during the first year of treatment to curtail any potential problems.

"Who is the right patient to receive rimonabant? Not everybody," Sanofi-Aventis's Richard Gural told the panel. The drug is not appropriate for anyone with a history of depression or suicidal thoughts, or who is taking antidepressant medication, he added.

The company proposes selling the drug under the brand name Zimulti. Rimonabant is being sold in Europe as Acomplia.

Used with a modest-calorie diet and physical exercise, the drug significantly decreases body weight and waist circumference in overweight or obese patients, Sanofi-Aventis says.