On June 14, 2007, a federal advisory panel to the U.S. Food and Drug Administration (FDA) unanimously voted against the approval of Acomplia, all but assuring the FDA will not approve Sanofi-Aventis’ new diet drug for U.S. sale. If approved, it would be marketed as Zimulti in the United States. The drug is known generically as rimonabant.

The panel’s rejection is on the grounds that the drug increases the risks of neurological and psychological problems, such as suicidality, depression, anxiety, and aggression. Dr. Jules Hirsch is a research physician at Rockefeller University who served on the panel.

“I couldn’t in any way suggest that it be approved at the present time for use,” he said.

Sanofi originally designed the drug to block brain receptors that make a person feel hunger. Dr. Amy G. Egan, an FDA staff medical reviewer, presented data showing the drug doubled a patient’s risk of psychological problems.

“The potential market for this drug and the continued uncertainty about its risks, both known and unknown, lead to our concern about the use of this drug in the general population,” she said.

Source: Stephanie Saul, “F.D.A. Panel Votes Against Weight-Loss Drug,” New York Times, June 14, 2007.