EMEA recommends tougher labeling for Acomplia

The European Medicines Agency (EMEA) says that French pharmaceutical group Sanofi-Aventis' anti-obesity drug Acomplia (rimonabant) should not be used by patients suffering major depression, or those who are receiving anti-depressant medication, due to the potential risk of psychiatric side effects. The news follows the firm's withdrawal of its US approval application earlier in the month (Marketletter July 9).

The EMEA said that the drug, which has been available as an adjunct to diet and exercise in the treatment of obesity since last summer (Marketletter May 8, 2006), has carried warnings of potential psychiatric side effects since it was launched. The agency added that, having conducted a review of all information on potential side effects provided by Sanofi, it has concluded that, while the drug's benefits continue to outweigh its risks for the majority of users, this was not the case in patients suffering from depression.

The EMEA also said that any patient experiencing depression as a result of taking Acomplia should discontinue treatment, adding that it would be issuing a letter detailing the additional safety information to physicians in due course. Despite the announcement, the firm's share price improved 1% to 62.26 euros in trading on Paris Bourse on July 20.