These drugs lose their marketing authorization. They are said to have modest efficacy in the management of type 2 diabetes, and would entail risks of heart valve damage. The National Pharmacovigilance Commission and the National Marketing Authorization Commission considered that the benefit / risk balance of benfluorex-based drugs was not favorable.
The three drugs concerned are Mediator 150 mg, marketed by Servier laboratories since 1976, and two generic drugs. These have been put on the market by Mylan and Qualimed laboratories since October 2009.
Mediator has been under active surveillance in recent years, resulting in more information about these neuropsychiatric effects in 2005. Since 2007, a new assessment has led to a deletion of its indication for people with a high rate of fat in the blood.
Since that date, drugs containing benfluorex have only been indicated in overweight diabetic patients, in addition to an appropriate diet.
Pending the withdrawal of these drugs from pharmacies on November 30, patients treated with this molecule are invited to stop their treatment, and to consult their doctor without emergency to balance their diabetes, if necessary.
The doctor could also check for possible symptoms of valve damage, such as shortness of breath on exertion, for example.
Source: www.afssaps.fr
