The European Medicines Agency (EMEA) has recommended that the licence for Acomplia® from the company Sanofi-Aventis be suspended across the EU. The EMEA’s Committee for Medicinal Products for Human Use (CHMP) has assessed that the benefits of the rimonabant-containing Acomplia® no longer outweigh its risks.
The CHMP assessment has now been submitted to the European Commission for it to pass a decision with effect for all EU countries. Acomplia® has been on the Danish market since 2006 and is sold in 18 EU countries.
Acomplia® has been recommended in supplement to diet and exercise for the treatment of obese patients or overweight patients who want to lose weight. The authorities have warned against psychiatric side effects from the beginning, with focus on the risk of developing depression in particular. The product information for Acomplia® has been continuously updated, which has narrowed the group of patients which the medicinal product is recommended for and resulted in upgraded warnings.
Based on the latest experience, the medicinal product was assessed on the 20-23 October 2008 meeting. The CHMP assessed that obese or overweight patients taking Acomplia® have a two-fold risk of developing psychiatric disorders compared to those who take ineffective medicine (placebo).
The CHMP also considered data from the medicinal product’s time on the market and data from clinical trials. It has been assessed that clinical trials indicate that serious psychiatric disorders may be more common than the clinical trials prior to approval had shown. The CHMP also found that new warnings and limited use of the product cannot adequately reduce the risk of psychiatric side effects. In addition, the CHMP noted that the positive effects of Acomplia® are more limited than anticipated initially because patients take Acomplia® for a shorter period than recommended.
In 2007, 5604 Danes were prescribed Acomplia®. The Danish Medicines Agency has received 70 reports about side effects from the product.
The Danish Medicines Agency recommends patients, pharmacies and doctors to take the following action:
If you are treated with Acomplia®, you are advised to discuss your future treatment with your doctor. There is no need to stop treatment with Acomplia® immediately, but if you wish to stop you can do so at any time.
Doctors are encouraged not to issue any further prescriptions for Acomplia®. The doctor should evaluate the patient’s total risk factors and the need for treatment with an alternative weight-loss product. Pharmacies are encouraged to advise patients who present a prescription for Acomplia® to consult their doctor for a renewed clinical assessment.
You can download the EMEA press release, questions and answers to Acomplia®, and the summary of product characteristics (SPC) in the factbox to the right. Here you can also see the Danish Medicines Agency's previously issued announcements on Acomplia®.
For further information, please contact Chief Medical Officer Steffen Thirstrup, tel. +45 2246 7811.
Danish Medicines Agency, 23 October 2008.
