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Pharmaceutical Services Negotiating Committee

Drug Tariff News

Europe wide suspension of Marketing Authorisation for Acomplia (Rimonabant)

The European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CMHP) has today recommended the suspension of the Marketing Authorisation for Acomplia because the benefits no longer outweigh the risks. The most recent assessment by the CHMP looked at the available data for the benefits and risks associated with Acomplia (rimonabant), including studies that have been completed since its approval. The analysis showed that there was approximately a doubling of the risk of psychiatric disorders in obese or overweight patients taking Acomplia compared to those taking a placebo (a dummy pill).

Advice for patients

Patients currently taking Acomplia should consult their doctor or pharmacist when convenient to discuss their treatment. Patients who wish to stop taking Acomplia can do so at any time.Patients who are currently enrolled in clinical trials of rimonabant may wish to contact the trial investigator (the doctor who is treating them), who will be able to give more information. Trial investigators are being notified of this suspension of the marketing authorisation.

Advice for healthcare professionals

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.

More information can be found here.

Posted 27 October 2008

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