Over the last thirty years approximately 500 patients in France who took Mediator have died, French health agency CNAM (Caisse Nationale d'Assurance Maladie) has announced today. French watchdog Agence Française de Sécurité Sanitaire des produits de Santé (AFSSAPS) is urging all patients who have taken the medication to see their doctor to check for dangerous thickening of the heart valves. AFSSAPS added that a further 3,500 people who have taken the drug since its approval in 1976 have been hospitalized.
Mediator was prescribed to over 300,000 patients. Some of them experienced complications, mainly heart problems. The medication was discontinued in France last year, and soon after by the European Medicines Agency.
Mediator (benfluorex hydrochloride) was approved in 1976 in France. In 1987 it was approved as a medication, along with diet, for patients with hypertriglyceridemia (excessive blood triglyceride levels). It was approved in 1990, together with diet for diabetes or overweight patients. An application for approval for type 2 diabetes patients in primary care was turned down due to lack of efficacy data. In 2007 approval was withdrawn for hypertriglyceridemia treatment after reassessment of efficacy studies. (Everything in this paragraph refers to Mediator's regulatory history just in France)
Le Union Nationale Des Omnipraticiens De France, the country's union of general practitioners (primary care physicians) informs that it is ready to test patients who took Mediator for at least three months during the last four years.
French Health Minsiter, Xavier Bertrand, said:
- "Our message to all those who took Mediator is that they must see a doctor - particularly those who took it for three months over the past four years."
Mediator was made by French drugs firm Servier, the country's second-largest pharmaceutical group, which rejects the death estimates as a "theory founded on extrapolation". Even if one were to accept the official figures, the risk is still only 0.005%, the company says. Servier has sold a total of 145 million boxes of the medication in France.
Critics say French authorities have been too slow in banning the drug, after repeated warnings of its dangers.
Written by Christian Nordqvist