By Nigel Praities
The obesity drug sibutramine has had its licence suspended by the European authorities due to concerns over an increased risk of cardiovascular events with the treatment.
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.
UK GPs have been told to review patients after the licence for sibutramine was suspended The chequered history of obesity drugs
February 1998: Sibutramine launched in the UK – a centrally acting appetite suppressant- the first in the ‘new generation’ of obesity treatments
September 1998: Orlistat launched – acts locally on the GI tract to reduce the absorption of dietary fat
July 2006: Rimonabant launched in the UK a centrally acting, cannabinoid receptor antagonist
October 2006: The first reports suggesting side effects with rimonabant- particularly depression – are more common in practice than in clinical trials
October 2008: The European Medicines Agency recommend GPs not prescribe rimonabant due to the risk of psychiatric side effects. The drug is suspended ‘temporarily’
January 2009: Orlistat goes OTC in the UK as alli – at 60mg, half the dose of the prescription product Xenical
December 2009: Both the EMEA and the US Food and Drug Administration warn about a potential cardiovascular safety risk with sibutramine in patients at higher risk of CVD
January 2010: The MHRA announces the suspension of sibutramine as ‘the increased risk of non-fatal heart attacks and strokes with this medicine outweighs the benefits of weight loss’