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EMA Suspends Anti-Obesity Drug Over Psychiatric Concerns

Posted on: Thursday, 23 October 2008, 15:44 CDT

The European Medicines Agency is recommending doctors do not prescribe the anti-obesity drug rimonabant, also known as Acomplia.

The European watchdog group has said the risk of serious psychiatric problems and even suicide is too high.

Since at-risk patients cannot be identified, marketing of the drug should be suspended, the EMEA said. Patients taking the drug should consult their doctor, but do not need to immediately stop taking the medication.

Rimonabant, which is used in conjunction with diet and exercise, was prescribed to at least 97,000 people in the UK who are obese or overweight. Figures suggest approximately 20,000 are currently taking the drug.

The NHS watchdog approved Rimonabant in June this year for use in England and Wales.

Concerns over the risks of depression and suicide associated with the drug have lingered for some time, and in July last year, the EMEA warned it may be unsafe for patients also taking anti-depressants.

The drug was never recommended for patients with a history of major depression, and doctors were warned to be alert for new symptoms of depression in patients taking the drug.

But data from Sanofi-Aventis and more recent studies have shown double the risk of psychiatric disorders in obese or overweight patients taking rimonabant compared to those taking dummy pills.

There were five suicides among patients taking part in a trial who were on the drug between June and August 2008, compared with one among those taking the dummy version.

The drug was less effective in reality than clinical trials had suggested, as patients only tended to take it for a short period, according to the EMEA's Committee for Medicinal Products for Human Use, which assessed the new evidence.

The EMEA released a statement warning: "Prescribers should not issue any prescriptions for Acomplia [rimonabant] and should review the treatment of patients currently taking the medicine.

"Patients who are currently taking Acomplia should consult their doctor or pharmacist at a convenient time to discuss their treatment.

Dr. June Raine of the UK's Medicines and Healthcare products Regulatory Agency (MHRA) seconded the EMEA's advice and Professor Steve Field, chairman of the Royal College of GPs, said he was not surprised by the decision.

"I was concerned when the drug was first approved, so I support the EMEA."

Sanofi-Aventis also released a statement that said it would comply with the EMEA's decision, but that it believed rimonabant would remain "an important therapeutic answer to a highly prevalent and increasing unmet medical need".

"My patients were doing very well on it, and they will now have to stop and come off it," said Dr. Colin Waine, chairman of the National Obesity Forum.

"Patient safety must be foremost, but I always thought that if you ruled out the patients with depression, you ruled out the problem with the drug."

Waine said there is no need for patients to stop treatment with Acomplia immediately, but patients who wish to stop can do so at any time.

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On the Net:

• European Medicines Agency

Source: redOrbit Staff & Wire Reports

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