October 24, 2008
A DRUG used by about 3,000 Irish people to treat obesity has been withdrawn from the market after it was found to double the risk of psychiatric disorders, writes Genevieve Carbery
The prescription drug, Acomplia, used in Ireland since 2006, was suspended by the Irish Medicines Board (IMB) following a recommendation by the European Medicines Agency yesterday.
"There is an approximate doubling of the risk of psychiatric disorders in obese or overweight patients taking Acomplia compared to those taking a placebo," the agency said in a statement.
Such psychiatric side-effects include depression, sleep disorders, anxiety and aggression, the agency said. Warnings about the side effects have been included in the product information.
Some 47 suspected adverse drug reactions to Acomplia have been recorded in Ireland since 2006.
"The benefits no longer outweigh the risks," the European agency said yesterday. Side-effects may be more common than the clinical trials showed and the effectiveness of the drug in treating obesity was "more limited than expected", the agency said.
"Since the medicine has been on the market an increasing number of cases of serious psychiatric disorders including suicide have been reported," the agency said.
Internationally, five cases of suicide were reported in studies of patients taking the drug between June and August 2008, compared with one taking the placebo, the agency added.
The IMB said it had been in contact with GPs about the drug and was advising patients to see their doctor. It said patients currently taking the drug should stop doing so and seek advice from their GP.
"No further prescriptions for Acomplia should be prescribed or dispensed by doctors and pharmacists," said Dr Joan Gilvarry, the board's director of human medicines.
As well as being used for obesity, Acomplia has been used to treat overweight patients at risk of type two diabetes or abnormal levels of fat in their blood.
Acomplia contains the active substance rimobant and is the first in a new class of drugs that switch off the same brain circuits that make people hungry when they smoke cannabis.
It has been marketed in 18 EU countries, including Ireland, since 2006. Worldwide, more than 700,000 patients have been treated with Acomplia to date. It was refused marketing clearance in the United States last year.
Manufacturer Sanofi-Aventis yesterday said it was "complying with the European agency's recommendations to suspend the marketing authorisation of the drug to obese and overweight patients".