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Sibutramine: withdrawn from the European market at last!

Sibutramine is an amphetamine-based appetite suppressant with an unfavourable risk-benefit balance due to adverse cardiovascular effects.

The June 2001 issue of Prescrire ran a review of the licensing of sibutramine entitled "Not Acceptable": "it is unreasonable to expose obese patients to a risk of adverse effects (especially a rise in blood pressure) in the hope of losing a few kilograms, especially as the effects wane after treatment cessation".

This appetite suppressant is related to amphetamines, and causes similar adverse effects, especially cardiovascular. Cases of increased blood pressure and arrhythmia associated with sibutramine have long been reported.

The European Medicines Agency commissioned a study on sibutramine and on the basis of the findings decided to suspend sibutramine’s marketing authorisation at the end of January 2010.

Some 10,000 obese patients with a history of cardiovascular disease or type-2 diabetes, plus a cardiovascular risk factor, were included in the 2002 study. According to the results published in 2009, sibutramine increases the frequency of cardiovascular complications: 11.4% of the patients prescribed sibutramine have had a cardiovascular event (cardiac infarction, stroke, resuscitated cardiac arrest or death), versus 10% treated with placebo.

Obesity itself is a cardiovascular risk factor, which sibutramine exacerbates. Too bad for patients that it has taken 9 years for this drug to be withdrawn from the European market.

©Prescrire July 2010

"Sibutramine: cardiovascular events" Prescrire Int 2010; 19 (107): 125. (pdf, subscribers only)

Download the full review 
Pdf, subscribers only