By Joanne Bladd
All marketing of drug in Middle East suspended amid psychiatric disorders link.
Sales of the anti-obesity drug rimonabant have been suspended across the Middle East, after Europe’s top drug watchdog linked the pills with an increased risk of psychiatric problems and suicide.
The European Medicines Agency (EMEA) found patients taking the drug had twice the risk of psychiatric disorders compared to those taking a placebo.
More recent studies showed that, between June and August 2008, there were five suicides among patients taking part in a trial for the medication.
The drug, which is also known as Acomplia, was released to the United Arab Emirates (UAE) market in June of this year.
Dr Hisham Mahmoud, Gulf medical director for sanofi-aventis, the manufacturer of the drug, said all marketing activities for the pills would be terminated following the EMEA’s decision.
“There will be no activities from the company at all until there is a future reevaluation of Acomplia,” he told Medical Times.
“There will be a message sent out to doctors, pharmacists and patients to say the drug is not to be prescribed and no old prescriptions renewed.”
The company has not waited for the UAE’s own drug agency to take a decision on rimonabant, Dr Mahmoud said, in a bid to pre-empt the pills being pulled permanently from the local market.
“We are encouraging the temporary suspension of the drug, but we are really discouraging full withdrawal, because that would mean slashing the registration status of the drug,” he said.
The company met with the UAE’s Ministry of Health yesterday morning, but the agency has not yet released a formal statement.
The EMEA, however, has banned doctors from issuing any new prescriptions for rimonabant and has advised patients to contact their doctor to review their treatment.
It is thought only a small number of UAE patients will be affected, as the drug has only been available in the country for six months.
Rimonabant has been dogged with controversy since its launch.
The medication, which is available in Kuwait, Lebanon and Israel as well as the UAE, was denied approval in the United States last year following concerns over its link to mental health disorders.
Rimonabant was previously touted as sanofi’s next potential blockbuster, having been taken by around 700,000 patients worldwide.
The French drug-makers shares have plummeted following the latest revelations.
Rimonabant sales will be suspended until at least 2010, Dr Mahmoud said, as ongoing clinical trials – giving fresh data on the drug’s use - are not expected to conclude until late 2009, at the earliest.
Sanofi-aventis is hopeful further trials will support the drug’s safety profile and allow marketing to resume. In a statement, the drug-maker reiterated its belief that rimonabant’s benefits to patients outweigh its risks.