Sanofi's anti-obesity drug Acomplia pulled out of EU

The European Medicines Evaluation Agency (EMEA) has recommended the suspension of the anti – obesity drug rimonabant, better known by its brand name Acomplia on account of concerns that it may increase depression, sleep disorders, anxiety and aggression in some overweight or obese patients.

The EMEA said that since it was not possible to identify and isolate those patients who would be at risk, the marketing of the drug should be suspended.

Doctors too have been advised to stop prescribing the anti-obesity drug as it poses a risk of psychiatric disorders and suicide, by the Medicines and Healthcare products Regulatory Agency (MHRA), which is responsible for drug safety in the UK. The agency has told doctors not to issue any new prescriptions for Acomplia.

Reports suggested that around 97,000 patients in the UK have been prescribed Acomplia, with 20,000 people currently taking it. As part of its warning, the EMEA said that patients should consult their doctor or general practitioner, although there is no need to immediately stop taking the drug.

In a statement on its website, Sanofi-Aventis, the manufacturer of the drug, said it would comply with the European authorities request to temporarily suspend the marketing authorisation of Acomplia in obese and overweight patients.

The company said it is committed to provide additional evidence for the re-evaluation of the benefit / risk profile of Acomplia in patients with diabetes and cardiovascular diseases through the ongoing clinical studies, and said that the drug provided ''significant clinical benefits''.

Sanofi-Aventis said Acomplia has been marketed in 18 European Union (EU) countries since 2006, and has provided significant clinical benefits to patients suffering from obesity and overweight with associated co morbidities. It said that over 700,000 patients globally have been treated with Acomplia till date.

The National Health Service (NHS) had approved Acomplia for use in June, even though concerns about the risks of depression and suicide amongst users have persisted. In July 2007, the EMEA warned that the drug might be unsafe for patients who have also been prescribed anti-depressants.

Reports suggested that data from recent studies by Sanofi-Aventis showed that patients taking Acomplia had twice the risk of developing psychiatric disorders as compared to given a placebo. They said that five out of 36,000 patients on a trial committed suicide between June and August, while only one did so from amongst those taking the placebo.

Reports also said that the effectiveness of the drug was reduced by the fact that patients stayed on it only for a short while, even as the risks appeared higher than previously imagined. They also said that the EMEA's committee for medicinal products for human use said that it had concluded that the benefits of Acomplia ''no longer outweigh its risks".

Acomplia had also been refused marketing clearance in the US on account of its risks of depression and suicide.

Acomplia had been touted earlier as a multibillion-dollar seller. However, sales in the first nine months of 2008 managed only €81 million according to reports.

Another drug manufacturer, Merck & Co, was reported to have decided against the further development of a similar experimental drug called taranabant, in the light of revelations from data of a late-stage clinical study that suggested more side effects at higher doses.