The European Medicines Agency (EMEA) has recommended that the product licence for rimonabant (Acomplia®) is suspended. This announcement has reached the general media (BBC).
The Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of rimonabant no longer outweigh its risks and the marketing authorisation should be suspended across the European Union (EU). This decision has been reached because post-marketing experience indicates that serious psychiatric disorders may be more common than in the clinical trials
The Medicines and Healthcare products Regulatory Agency have written to healthcare professionals (PDF) with the following advice:
- Prescribers should not issue any prescriptions for rimonabant, and should review the treatment of those who are currently taking this medicine
- Patients who are currently taking rimonabant should consult their doctor or pharmacist at a convenient time to discuss their treatment. If patients wish to stop taking rimonabant, it is safe to 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
Action: Clinicians should be aware of the licence suspension. No new prescriptions should be issued and patients currently using this medication should be advised to return it to a pharmacy for destruction.