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Anti-obesity drug use suspended

Watchdog says drug’s risks outweigh its benefits

OnMedica staff

Friday, 24 October 2008

Doctors are being warned not to prescribe the drug rimonabant (Acomplia) because its risks are greater than its benefits.

The European Medicines Agency (EMEA) has recommended suspension of the marketing authorisation for rimonabant across the European Union.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has backed the advice

EMEA’s committee for medicinal products for human use concluded that the benefits of the drug no longer outweighed risks such as serious psychiatric disorders and depression.

It is estimated that around 97,000 people in the UK have been prescribed rimonabant and around 20,000 are currently taking it.

The EMEA has advised that these people do not need to stop treatment immediately, but said they should consult their doctor or pharmacist to discuss their treatment.

The drug has been authorised in the EU since June 2006 as an additional aid to diet and exercise for treating obese or overweight patients with associated risk factors. It is marketed in 18 countries including the UK.

Warnings about psychiatric side effects, in particular depression, have been included in the product information since the drug was first authorized and the product information has been updated and strengthened to manage the risks associated with the use of rimonabant.

Following assessment of available information on the benefits and risks of the drug, including data from studies completed, EMEA decided this week that there is an approximate doubling of the risk of psychiatric disorders in obese or overweight patients taking the drug compared to those taking placebo.

The suspension of a marketing authorisation is a precautionary measure, during which time a medicinal product is not available. The lifting of the suspension is conditional on the marketing authorisation holder resolving the issues identified by the Agency.

A MHRA spokesperson said: "Prescribers should not issue any prescriptions for Acomplia and should review the treatment of patients currently taking the medicine. A letter is being sent to healthcare professionals about this announcement, through the Department of Health's Central Alerting System.

“Patients who may be at highest risk of psychiatric reactions cannot be identified reliably. Therefore, further restrictions on the use of this medicine would be unlikely to reduce the risk to an acceptable level.”

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