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EMA resources stretched by Mediator scandal

The European Medicines Agency has been forced to use ‘considerable resources’ to deal with a flood of enquiries over Mediator after safety concerns caused it to be withdrawn from the French market in November 2009.

Mediator (benfluorex) was developed by French firm Servier as a diabetes treatment, but millions of people used it to help them lose weight. 

New research suggests it is linked to at least 500 deaths in France between 1976 and November 2009, but it remained on the French market despite evidence suggesting its serious risks.

France cleans up regulation - and restricts pharma role

Health minister Xavier Bertrand
France’s health minister Xavier Bertrand: pharma must be kept at a distance

France has unveiled sweeping changes to how it regulates prescription medicines following the scandal surrounding Servier’s Médiator.

Health minister Xavier Bertrand says new regulation will strengthen pharmacovigilance, create greater transparency and more declaration of interests at all levels of regulation and government.

The controversy has generated considerable distrust of pharma industry practices in France, with Servier’s alleged close connections with doctors and regulators blamed for the drug staying on the market.

French pharma firm denies drug risk cover up

France’s second biggest pharma firm Servier has denied allegations it concealed risks associated with its diabetes drug Mediator (benfluorex).

Research by France’s national institute of health research says the drug could be responsible for around 1,000 – 2,000 deaths in France between 1976 and 2009, but in an email Servier insisted the estimates show ‘imprecision in the analysis’.

Pressure mounts on Servier over Mediator controversy

Mediator patient representative
Patient representatives are seeking to sue Servier for alleged damage caused by Mediator

Dr Jacques Servier has stepped down from his role as head of a French pharma industry association as controversy grows around the Mediator affair.

Dr Servier is the president and founder of the pharmaceutical company Servier, which has been caught up in a major safety scandal concerning its diabetes treatment Mediator (benfluorex).

Servier's Mediator provokes French drug safety controversy

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

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