Following the results of a study showing that the product could increase the risk of cardiovascular complications in certain patients, and pending a decision from the European Commission, the French Agency for the Safety of Health Products (Afssaps) invites prescribers to stop initiating or renewing sibutramine treatments. It also recommends that patients treated with Sibutral consult their doctor in order to stop or change their treatment.
Sibutramine is prescribed as part of adjunctive treatments intended to control the weight of obese patients with a body mass index greater than 30. A recent study analyzed by the European Medicines Agency showed an increased risk of cardiovascular complications in patients treated with Sibutral.
Nearly 5,500 patients are currently undergoing treatment with Sibutral in France. Since its marketing in June 2001, around sixty reports of adverse effects linked to this drug have been reported to Afssaps.
