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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.
https://www.cas.dh.gov.uk/Home.aspx
What is Acomplia?
Acomplia is a medicine containing the active substance rimonabant. It is used together with diet and exercise to reduce weight in adult patients who are:
- obese (very overweight) with a body mass index (BMI) greater or equal to 30 kg/m 2, or;
- overweight (BMI greater or equal to 27 kg/m 2) and also have other risk factors, such as type 2 diabetes or dyslipidaemia (abnormal levels of fat in their blood).
Acomplia has been authorised in the European Union (EU) since June 2006 and is marketed in 18 European member states.
What is the issue with Acomplia?
At the time of Acomplia’s approval, psychiatric side-effects (particularly depression) were identified as the most important safety issue and relevant warnings were included in the product information since its first authorisation. Since then, the CHMP has been monitoring the medicine closely and changes to the product information have been introduced as new data become available.
The CHMP recommended a further update in March 2008 to reflect new information on psychiatric reactions and to advise prescribers to monitor patients for signs and symptoms of psychiatric disorders, particularly depression, after the start of treatment.
The MHRA alerted healthcare professionals to this the May issue of the Drug Safety Update 2008.
Further European assessment of rimonabant has concluded that the risks of treatment outweigh the benefits in clinical use. Therefore, the European Committee for Medicinal Products for Human Use has recommended that the marketing authorisation for this medicine should be suspended across the European Union.
The measures and clinical advice implemented to date to try to reduce the frequency of psychiatric reactions (particularly depression) with rimonabant have not adequately controlled this risk. 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.
For further information please go to the EMEA website www.emea.europa.eu
Rimonabant: Letter sent to healthcare professionals 
