European Medicines Agency Recommends Suspension Of Marketing Authorisations For Sibutramine

Another appropriate blow for the IMHO malpractice known as diet drugs.

The European Medicines Agency has finalised a safety review of medicines containing sibutramine. 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.

Sibutramine-containing medicines are authorised as Reductil, Reduxade and Zelium and other tradenames in the European Union. They are used to promote weight-loss in obese patients and in overweight patients who also have other risk factors such as type-2 diabetes or dyslipidaemia (abnormal levels of fat in the blood), together with diet and exercise.

Doctors 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. Patients who wish to stop treatment before seeing their doctor can do so at any time.

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 heart attack, with sibutramine compared with placebo. The SCOUT trial, in which nearly 10,000 patients were enrolled for up to six years, was designed to determine the impact of weight loss with sibutramine on cardiovascular problems in a large group of overweight and obese subjects with known or high risk for cardiovascular disease.

Now if they would only protect patients and do the same for bariatric surgery.