Obesity drug pulled over suicide risks

Doctors have been told to stop prescribing the anti-obesity drug rimonabant, whose brand name is Acomplia, because it poses a risk of psychiatric disorders and suicide.

The European Medicines Evaluation Agency recommended suspension of the drug yesterday amid concerns that it may increase depression, sleep disorders, anxiety and aggression in some overweight or obese patients. As the patients at risk cannot be identified, marketing of the drug should be suspended, the EMEA said.

The Medicines and Healthcare products Regulatory Agency (MHRA), which is responsible for drug safety in Britain, said doctors should not issue any new prescriptions for Acomplia.

An estimated 97,000 patients in the UK have been prescribed Acomplia and 20,000 are currently taking it. The EMEA said patients should consult their GP but did not need to stop taking the drug immediately.

Acomplia was approved for use on the NHS in June. However, concerns about the risks of depression and suicide among users have been expressed for some time. In July 2007, the EMEA warned it could be unsafe for patients taking anti-depressants. Data from recent studies and from the maker, sanofi-aventis, has revealed patients taking Acomplia have twice the risk of developing psychiatric disorders compared to those given a placebo. Five patients among 36,000 on a trial of the drug committed suicide between June and August, compared to one suicide among those taking the placebo. While the risks appeared higher than previously thought, the drug has proved less effective because patients only stay on it for a short time. The EMEA said its committee for medicinal products for human use "has concluded that the benefits of Acomplia no longer outweigh its risks".

Acomplia has been authorised in the EU since June 2006 to be used alongside diet and exercise to treat obese or overweight patients. It has been "moderately effective", the EMEA said.

Sanofi-aventis said it would "comply with the European authorities' request to temporarily suspend the marketing authorisation of Acomplia in obese and overweight patients". It said it would provide further evidence from clinical studies to aid the re-evaluation of Acomplia, adding that the drug provided "significant clinical benefits".

97,000 patients

Estimated number of people in the UK who are prescribed Acomplia.