Since January 2010 the European Medicines Agency EMA has recommended suspending the marketing authorisation for the appetite suppressant sibutramine (REDUCTIL). The agency is thus drawing the conclusions from a safety review showing that the risks of this medicine outweigh its benefits. The review was prompted by the results of the long-term randomized interventional study SCOUT* (1). In this study involving around 10,000 overweight patients with known cardiovascular disease or type 2 diabetes and at least one other cardiovascular risk factor, the incidence of a serious cardiovascular complication (heart attack, stroke, cardiac arrest or death of cardiovascular origin) is significantly higher in sibutramine users than placebo users (11.4% vs. 10%; hazard ratio 1.161, 95% confidence interval 1.029-1.311; number needed to harm = 71; a-t 2009; 40: 110) (2). The study, which has not yet been published in full, confirms the suspicion existing since the product's launch ten years ago that the cardiovascular risk is increased by this appetite suppressant, which can raise blood pressure and pulse (a-t 1999; No. 2: 23-4 and 2003; 34: 88). By contrast, the EMA views the weight loss achievable with sibutramine as relatively small and hence the benefit-risk balance is negative (1). The marketing authorisation is to be suspended unless fresh data are provided that would make it possible to identify users with a clear positive benefit-risk balance (3). Based on experience, however, a measure of this kind means a final farewell to the product. Immediately after the EMA decision became known, the sibutramine supplier Abbott announced that marketing of sibutramine in the EU was being suspended (4). In Germany the medicine has now been recalled from pharmacies (5).

1

EMA Press Release: European Medicines Agency recommends suspension of marketing authorisations for sibutramine, 21 January 2010

2

Abbott: Dear Doctor Letter, 22 January 2010

3

EMA: Questions and answers on the suspension of medicines containing sibutramine, 21 January 2010;
http://www.ema.europa.eu/pdfs/human/referral/ sibutramine/Sibutramine_Q&A_80817909en.pdf

4

Abbott Germany: Press Release, 21 January 2010; http://www.abbott.de/press/show/e7340/e18095/index_de.html

5

Pharm. Ztg. 2010; 155 (No 4): 143

*

SCOUT = Sibutramine Cardiovascular Outcome Trial