FDA staff expresses concern over Sanofi's weight loss drug

FDA staff expresses concern over Sanofi's weight loss drug
WASHINGTON - The US Food and Drug Administration staff has expressed concern over an increase in suicidal behavior in volunteers who tool Sanofi Aventis' weight loss drug, rimonabant. The drug is under review and FDA panel is due to meet today to decide whether to recommend the drug for approval.

In Europe the drug is already approved and sold under the name Acomplia. As per documents available with the FDA, rimonabant was able to reduce 5 percent body weight when combined with low-calorie diet. However the decision on the drug, which will be marketed under the name Zimulti if approved, has already been delayed three times.

"We remain concerned about rimonabant's adverse event profile, specifically adverse psychiatric reactions," an FDA staff statement said. The reviewers said mental issues "represent the most common and worrisome rimonabant-induced adverse events."

Sanofi admitted suicidal thoughts were prevalent with the drug and asked FDA not to recommend it to those who suffered from depression.

But the company also said the drug's other benefits like reducing cholesterol and blood sugar "clearly outweigh the defined risks that are manageable in clinical practice." After the panel recommendation, the FDA is likely to issue a final decision in July.