October 24, 2008 

The European Medicines Agency (EMEA) has recommended that marketing of Acomplia (rimonabant) be suspended in the Europe Union due to concerns about psychiatric side effects.  The EMEA's Committee for Medicinal Products for Human Use (CHMP) found that the benefits associated with Acomplia no longer outweigh the psychiatric risks associated with the drug.  Following a review of data from studies completed since Sanofi-Aventis was granted marketing authorization (June 2006), the CHMP found that there is an approximate doubling of the risk of psychiatric disorders in obese or overweight patients taking Acomplia compared to those taking a placebo.  Acomplia is prescribed in addition to a diet and exercise plan for the treatment of obese patients or overweight patients with associated risk factors.  The EMEA is recommending that physicians should not issue any new prescriptions for Acomplia and should review the treatment plans of patients currently taking the drug.  However, they stated that there is no need for patients currently taking Acomplia to stop treatment immediately.  The CHMP's recommendation will be considered by the European Commission for adoption.

More information on the recommendation may be found in the following press release:

http://www.emea.europa.eu/humandocs/PDFs/EPAR/acomplia/53777708en.pdf

For further questions, please contact Stephanie Kutler, Associate Director of Government and Professional Affairs at skutler@endo-society.org.