FDA Shouldn't Approve Diet Drug, Panel Says

Concern about suicidal thoughts cited by agency advisers.

By Steven Reinberg
HealthDay Reporter
Thursday, June 14, 2007; 12:00 AM

Copyright © 2007 ScoutNews, LLC. All rights reserved.

WEDNESDAY, June 13 (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 Dr. Jules Hirsch, of The Rockfeller 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 wonder 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.

This side effect has delayed FDA approval, and is, as Dr. Eric Colman, deputy director of the FDA's metabolic and endocrine drugs office, told the panelists Wednesday, "obviously, a big concern for us," the AP reported.

The manufacturer, in its own testimony before the panel, agreed.

"Who is the right patient to receive rimonabant? Not everybody," Richard Gural, of Sanofi-Aventis, testified. The drug is not right for anyone with a history of depression or suicidal thoughts, or who has been diagnosed with depression or is currently taking antidepressant medication, he added, according to the AP.

Gural suggested that patients be screened for depression before they were prescribed the drug. He also recommended that patients visit their doctors five times during the first year of treatment to be reassessed, the AP said.

Despite the significant side effect, some experts said they believe the drug should be approved.

"Well-conducted, large clinical trials provide clear and compelling evidence that rimonabant facilitates weight loss," said Dr. David Katz, director of the Prevention Research Center at Yale University School of Medicine. "Those same trials suggest the drug is safe and generally well-tolerated. In my opinion, there is ample evidence to support FDA approval of rimonabant at this time."