This ‘Stop Press’ article in the February 2010 issue of Drug Safety Update highlights the CHMP’s recommendation that the EU licenses for sibutramine be suspended.  This follows a review conducted by the EMEA, on the basis of new safety information from the SCOUT (Sibutramine Cardiovascular OUTcomes) study, which concluded that the cardiovascular risks of sibutramine outweigh its benefits.   

In SCOUT, high-risk patients (overweight patients with cardiovascular disease and/or type 2 diabetes) randomised to sibutramine were found to have a 16% increased risk of cardiovascular adverse events compared with those treated with placebo (hazard ratio 1.161; 95% CI 1.029–1.311; p=0.016).  In addition the mean weight loss with sibutramine was modest across all clinical trials, and may not be sustained after treatment cessation.

The following advice is given:

• Doctors should not issue any new prescriptions for sibutramine, and should review the treatment of those who are currently taking this medicine
• Pharmacists should not dispense any prescriptions for sibutramine and should advise patients to make an appointment to see their doctor at the next convenient time
• Patients who are currently being treated with sibutramine should be advised to schedule an appointment with their doctor at the next convenient time to discuss alternative measures to lose weight, including use of diet and exercise regimes. Patients may stop sibutramine treatment before their appointment if they wish