Anti-obesity drug licence suspended amid safety fears

22 January 2010

GPs should stop prescribing anti-obesity drug sibutramine after its licence was suspended.

The move follows a safety review that showed an increased risk of non-fatal heart attacks and strokes with the drug, which is marketed as Reductil. The European Medicines Agency (EMEA) review concluded that the risk outweighed the benefits of weight loss, which was modest and may not continue long-term once treatment ended.

Prescribers are being advised by the MHRA not to issue any more prescriptions for sibutramine and to review the treatment of patients taking the drug. Pharmacists are being asked to stop dispensing the medicine and anyone taking the drug is advised to see their GP about alternative weight-loss methods. The MHRA said there are no health implications for those who choose to stop taking the drug before seeing their doctor.

Nearly 330,000 prescriptions for the drug were written in Britain in 2008. But a recent clinical trial of 10,000 patients over the past six years found the drug could lead to an increased risk of heart problems. The MHRA has recorded 2094 suspected adverse reactions to Reductil since it was introduced in 2001, and 17 deaths have been linked to the drug. Six of the deaths were caused by heart problems and strokes.

The drug was licensed for prescription for the clinically obese but the EMEA has recommended it should be discontinued.