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Sanofi-Aventis drug under scrutiny
Acomplia (rimonabant), a diet pharmaceutical from Sanofi-Aventis that received marketing authorisation from the European Union in June, is currently under scrutiny due to worries about the side effects of the compound.
The drug, a CB1 blocker, has been approved in Europe for the treatment of obesity and overweight patients with related risk factor conditions, including dyslipidaemia and type two diabetes.
Regulators in Europe have reported a dozen cases of psychiatric disorders in those taking Acomplia, half of which involving major depression, while there have been no long-term studies on the effects of CB1 blocking in the brain, BusinessWeek.com reports.
“It’s just the latest setback for a volatile company that’s struggling with a lot of issues,” Navid Malik, an analyst at Collins Stewart, told the website.
“I’m not convinced that the side effects, especially the psychiatric ones, are as minor as the company claims,” he added.
Acomplia received its third reimbursement of November after the Pharmaceutical Benefits Board in Sweden granted such payment for the treatment of obese patients with a body-mass index of over 35 kg per sq metre and overweight patients with a body mass index of 28 kg per sq metre and associated conditions.
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