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Servier's Mediator provokes French drug safety controversy

Published on 12/01/11 at 09:58am

Serious questions are being asked about drug safety monitoring in France in connection with Servier’s Mediator (benfluorex) which was withdrawn from the market in November 2009.

An initial study conducted following its withdrawal found Mediator, was linked to approximately 500 deaths in France between 1976 and November 2009, but Inserm, France’s national institute of health research says this figure could be much higher, between 1,000 and 2,000.

The drug was licensed to treat diabetes patients but was used extensively off label in France as a weight loss treatment.

France’s medicines regulator AFSSAPS had been alerted to the potential dangers of Mediator as long ago as 1998. The response was slow despite the withdrawal of a similar product, Isomeride, which Servier withdrew from the French market in 1997.

AFSSAPS is now under pressure to explain why it didn’t act sooner, with opposition politicians demanding a public inquiry, accusing it and the government of being too close to the pharma industry and failing to protect patients.

In an interview with the Le Figaro newspaper, health minister Xavier Bertrand admitted there had been ‘serious failures’ in the country’s licensing system. He said the drug safety monitoring system would be strengthened and proposed to systematically inform all countries of a withdrawal of the drug.

Servier voluntarily withdrew Mediator in Spain in 2003 and in Italy in 2004.

In Spain, the withdrawal of Mediator followed a first case of heart valve damage. France was one of the last countries to withdraw the drug.

Legal action has already been successfully taken against Servier in relation to Isomeride. In September a court in Nanterre found the company had committed misconduct and ordered it to pay €210,000 in damages to a patient who had developed severe heart problems after taking Isomeride.

Servier must also pay the health insurance fund of the Hauts-de-Seine region around €158,000 to cover care costs for the patient. Isomeride ran into similar problems in the US.

Known as Redux in the US, the drug’s withdrawal was ordered by the FDA in 1997, leading to a $12 billion settlement following class action by tens of thousands of patients.

Servier says problems with heart valves in patients with diabetes are hard to link directly to use of any drug. Nevertheless, the company is facing further legal action from claimants in France.

Andrew McConaghie

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