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European Medicines Agency Recommends Suspension of Sibutramine LONDON -- January 22, 2010 -- The European Medicines Agency has finalised a safety review of medicines containing sibutramine (Reductil, Reduxade, and Zelium). The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the risks of these medicines are greater than their benefits and recommended the suspension of marketing authorisations for these medicines across the European Union. Physicians should no longer prescribe, and pharmacists should no longer dispense the medicine. Patients currently taking sibutramine should make an appointment with their doctor at the next convenient time to discuss alternative measures to lose weight. The review was initiated because data from the Sibutramine Cardiovascular Outcome Trial (SCOUT) showed an increased risk of serious, non-fatal cardiovascular events, such as stroke or myocardial infarctions (MI), with sibutramine compared with placebo. The SCOUT trial, in which nearly 10,000 patients were enrolled for up to 6 years, was designed to determine the impact of weight loss with sibutramine on cardiovascular problems in a large group of overweight and obese individuals with known or high risk for cardiovascular disease. The CHMP noted that the use of sibutramine was not in accordance with the prescribing information for most of the patients enrolled in the SCOUT study, as sibutramine is contraindicated in patients with known cardiovascular disease. The treatment duration in the study was also longer than normally recommended. However, because obese and overweight patients are likely to have a higher risk of cardiovascular events, the Committee was of the opinion that the data from SCOUT are relevant for the use of the medicine in clinical practice. The Committee also noted that the data from available studies showed that the weight loss achieved with sibutramine is modest and may not be maintained after stopping. The CHMP was therefore of the opinion that the benefit of sibutramine as a weight-loss aid do not outweigh the cardiovascular risks. The Committee’s recommendation for the suspension of the marketing authorisations has now been forwarded to the European Commission for the adoption of a decision. SOURCE: European Medicines Agency E-mail this page to a friend or colleague! To print, use this version