EU Warns on Sanofi Drug

The agency said doctors in the EU have been warned about possible psychiatric side effects for 13 months, adding that medical advisors have recommended "upgrading" this warning.

"Psychiatric side effects, in particular depression, were identified as the main safety issue at the time of approval," the agency said. "They were reflected in the medicine's product information."

Last month, European health regulators asked Sanofi-Aventis to provide "all available information" on psychiatric side effects. They concluded "the benefits of Acomplia continue to outweigh its risks, except in patients with ongoing major depression or taking antidepressants."

Shares of Sanofi-Aventis were recently up 23 cents to $42.92.