EU Warns on Sanofi Drug

People with depression shouldn't use Acomplia, regulators say.
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A weight-loss drug from

Sanofi-Aventis

(SNY) - Get Report

took another hit Thursday when European health regulators said people with depression shouldn't use the drug.

Known as Acomplia in Europe, where it was approved 13 months ago, the obesity treatment was unanimously opposed by an advisory panel to the U.S. Food and Drug Administration last month. Advisors were

concerned that the drug, whose U.S. brand name is Zimulti, would cause psychiatric side effects.

The FDA was scheduled to vote on the drug in July, but it didn't get the chance. On June 29, Sanofi-Aventis

withdrew its application, adding that it is "committed to taking all steps necessary" to make the drug available.

The U.S. has been viewed by Sanofi-Aventis and by analysts as the key to achieving peak annual sales that some had forecast as high as $3 billion. The drug is approved in 37 countries and sold in 18, including large EU markets such as France, Germany and the U.K.

On Thursday, the FDA's counterpart in the EU said Acomplia shouldn't be prescribed for people "with ongoing major depression or who are being treated with antidepressants, because of the risk of psychiatric side effects."

The European Medicines Agency's proposal has been sent for a vote by the EU's governing body.

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.