The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Acomplia no longer outweigh its risks and that the marketing authorisation should be suspended across the EU.
The CHMP considered that new data from post-marketing experience and ongoing clinical trials indicated that serious psychiatric disorders may be more common than in the clinical trials used in the initial assessment of the medicine. The CHMP was also of the opinion that these psychiatric side-effects could not be adequately addressed by further risk minimisation measures.
Prescribers should not issue any prescriptions for Acomplia and should review the treatment of patients currently taking the medication. There is no need for patients to stop treatment with Acomplia immediately, but patients who wish to stop can do so at any time.
Further information: EMEA Q&A on recommendation to suspend Acomplia