EMEA begins review of sibutramine safety

The European Medicines Agency (www.emea.europa. eu) is reviewing the safety of the antiobesity drug sibutramine (Reductil) following new concerns about its cardiovascular safety.

The new data come from the Sibutramine Cardiovascular OUTcome (SCOUT) trial in patients at high cardiovascular risk. The original SCOUT report concluded that, after six weeks’ treatment, sibutramine was ‘efficacious, tolerable and safe in this high-risk population’ (Eur Heart J 2007;28: 2915-23).
    In 2009, a preliminary analysis of the primary end-point (a combination of heart attack, stroke, resuscitated cardiac arrest or death) suggested that sibutramine was associated with an increase in cardiovascular events compared with placebo (11.4 vs 10 per cent).
    Sibutramine is contra­indicated in patients with a history of coronary artery disease, congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease.