GPs told to review patients after obesity drug licence is suspended

22 Jan 10

The Medicines and Healthcare products Regulatory Agency announced today that a European-wide review had concluded the risk of heart attacks and strokes from sibutramine (Reductil) outweighs the benefit gained from weight loss.

NHS data show GPs issued over 330,000 prescriptions for sibutramine in 2008, but GPs have been advised not to issue any new prescriptions for sibutramine and to review the treatment of any patients taking the drug.

Both the European Medicines Agency and the US Food and Drug Administration announced reviews into sibutramine last December after a study found an excess of serious cardiovascular events in high-risk patients on the treatment.

Dr June Raine, director of vigilance and risk management of medicines at the MHRA said: 'Evidence suggests that there is an increased risk of non-fatal heart attacks and strokes with this medicine that outweigh the benefits of weight loss, which is modest and may not be sustained in the long term after stopping treatment.

'Prescribers are advised not to issue any new prescriptions for Reductil and to review the treatment of patients taking the drug.

'People who are currently taking Reductil are advised to make a routine appointment with their doctor to discuss alternative measures to lose weight. There are no health implications if people wish to stop treatment before seeing their doctor,' she said.

A spokesperson from the manufacturer of sibutramine said they would comply with the decision to suspend the licence, but did not agree the measure was neccessary.

Dr Eugene Sun, vice-president of global pharmaceutical research and development at 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,' he said.