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Rimonabant marketing authorisation suspended

Rimonabant (Acomplia) has had its marketing authorisation suspended across the EU following a safety review by the European Medicines Agency (EMEA). The review, initiated because of growing concerns about psychiatric side effects, has revealed that the risks of treatment outweigh any clinical benefits.

Although psychiatric side effects were identified as the most important safety issues when rimonabant was first approved in June 2006, new data from post-marketing experience, ongoing clinical trials and spontaneous reports of adverse effects from rimonabant suggest that serious psychiatric disorders might be more common in clinical use. Psychiatric disorders include depression, sleep disturbances, anxiety and aggression.

The EMEA’s Committee for Medicinal Products for Human Use has confirmed that there is an approximate doubling of the risk of psychiatric disorders in obese or overweight patients taking rimonabant compared with those taking placebo.

The EMEA is advising patients who are currently taking rimonabant to consult their doctor or pharmacist to discuss their treatment and says that if patients want to stop taking rimonabant it is safe to do so at any time.

Prescribers should not issue any prescriptions for rimonabant and should review the treatment of those who are currently taking the drug.
Ramiro Antuña de Alaiz
Education Treatment Unit
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