Withdrawal of sibutramine leaves European doctors with just one obesity drugBMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c477 (Published 25 January 2010) Cite this as: BMJ 2010;340:c477
- Anna Sayburn
European regulators have suspended the marketing authorisation for the weight loss drug sibutramine, and the US Food and Drug Administration has restricted its licence, amid concerns about a raised risk of heart attacks and strokes.
The European Medicines Agency recommended on Thursday 21 January that doctors stop using the drug because the risks outweigh the benefits. Its recommendation came after the agency’s committee for medicinal products for human use finalised a safety review, prompted by unpublished data from the sibutramine cardiovascular outcomes trial (SCOUT). This six year trial of 10 000 mostly European patients, which began in December 2002, showed a 16% rise in the risk of …