Tuesday, June 12, 2007

Accompli (Obesity Drug): To Be Released Drug - FDA Report

The obesity drug made by Sanofi-Aventis (Acomplia) may trigger suicidal behavior and other psychological side effects in some patients. The FDA posted on its site its review. There is a meeting on June 13, 2007 wehre experts will vote on whether it should be approved.

You can go here to read the notes in either PDF or HTML format.

From the report:

Although the literature is unclear with respect to the relationship between weight loss and depression, increased rates of psychiatric events, including depression, have been reported with weight loss agents in their package inserts: orlistat (Xenical) (depression: 3.4% versus 2.5% at Year 2) and sibutramine (Meridia) (depression: 4.3% versus 2.5%, and emotional liability: 1.3% versus 0.6%) for active drug versus placebo, respectively.

Stay tuned. The vote won't be close; my crystal ball says the vote will be for approval.