Anti-obesity drug sibutramine has licence suspended

Anti-obesity drug sibutramine (Reductil) has had its licence suspended and GPs are being asked not to issue any new prescriptions for the drug.

Prescribers are advised by the MHRA not to issue any new prescriptions for sibutramine (Photograph: DR P. MARAZZI/SPL)
Prescribers are advised by the MHRA not to issue any new prescriptions for sibutramine (Photograph: DR P. MARAZZI/SPL)

The suspension follows a review of the drug's safety by the European Medicines Agency (EMEA) on the basis of data from the Sibutramine Cardiovascular Outcomes study.

The review concluded there was an increased risk of non-fatal heart attacks and strokes with sibutramine. The EMEA said that this risk outweighed the benefits of weight loss, which was modest and may not have been sustained in the long term after stopping treatment.

Prescribers are being advised by the MHRA not to issue any new prescriptions for sibutramine and to review the treatment of patients taking the drug. Pharmacists are asked to cease dispensing the medicine.

People who are currently taking sibutramine are advised to make a routine appointment with their doctor to discuss alternative measures to lose weight.

The MHRA has said that there are no health implications if people wish to stop treatment before seeing their doctor.

Eugene Sun, vice president of global pharmaceutical research and development at manufacturer Abbott, said: 'We believe there are many patients who benefit from sibutramine and respectfully disagree with the committee's opinion and the recommendation to suspend the medicine.'

Last year, 86,000 people were prescribed sibutramine on the NHS. The drug was licensed for as adjunctive therapy within a weight management programme. Its indication was limited to patients with either nutritional obesity and a BMI of at least 30 kg/m2 or nutritional excess weight and a BMI of at least 27 kg/m2 in those with obesity-related risk factors.

The suspension of sibutramine follows the suspension of the marketing authorisation for rimonabant in October 2008. The EMEA decided that the benefits of rimonabant, which was marketed in Europe as Acomplia, no longer outweigh its risks.

 

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