Psychiatric Risk continued...
"The safety profile can only be interpreted in light of the demonstrated benefits," Paul Chew, MD, Sanofi-Aventis' vice president for international clinical development, told the committee.
But FDA scientists countered with an analysis of 13 studies showing that the drug nearly doubled suicidal thinking while also doubling cases of anxiety, depression, and other mood disorders.
Amy Egan, MD, an FDA safety official, says the agency had become worried because the company excluded patients being treated for depression from its analysis.
Several prescription weight loss drugs are already on the U.S. market, including Meridia and Orlistat. An over-the-counter version of Orlistat, known as Alli, is set to hit store shelves this week.
But Sanofi-Aventis took a novel approach to weight loss with Zimulti. The drug works by blocking the brain's cannabinoid receptors, the same receptors stimulated by marijuana. That seems to account for the drug's weight loss effect: blocking the same receptors that underlie the appetite- stimulating effect of marijuana.
Experts praised Sanofi-Aventis for what they said was an original approach to helping control obesity. "I think we all look forward to new data. I think this is an exciting area," says Clifford J. Rosen, MD, a senior scientist at the Maine Center for Osteoporosis and the panel's chairman.
- At what point do you say "no" to medication for weight loss? If taking it puts any of your organs at risk, is it worth it? Give us your take on WebMD's Dieting Clubs: 100+ Lbs. message board.