Thursday, October 23, 2008

The European Medicines Agency recommends suspension of the marketing authorisation of Acomplia

"The European Medicines Agency has recommended the suspension of the marketing authorisation for Acomplia (rimonabant) from Sanofi-Aventis. The EMEA's Committee for Medicinal Products for Human Use has concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorisation should be suspended across the European Union. Acomplia has been authorised in the EU since June 2006 as an adjunct to diet and exercise for the treatment of obese patients or overweight patients with associated risk factors. Warnings about psychiatric side effects, in particular depression, have been included in the product information since Acomplia was first authorised. The product information for Acomplia has been continuously updated and strengthened to include further contraindications and upgraded warnings on these concerns to manage the risks associated with the use of Acomplia" - EMA

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