#news France: 500 patients may have died after taking diabetes drug Mediator

A diabetes drug used as weight loss suppressant in France over 30 years is believed to have killed 500 people.

The drug Mediator that was produced by pharmaceutical firm Servier was used by millions but was banned in November 2009 over fears it was linked to heart trouble.

Drug samples in a Servier laboratory. The French Health Authority has warned the drug Mediator may have caused 500 deaths

Now the French Health Minister has called on patients who took the drug to go for an urgent check-up.

'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,' Mr Xavier Bertrand said.

It follows a warning issued by France's drug safety body Afssaps on Mediator's active ingredient since launching in 1976.

A statement from them said: 'Analyses by expert epidemiologists estimate that about 500 deaths could be attributable to benfluorex.'

The drug has also been banned in the United States, Spain and Italy. The drug was never authorised in the UK.

However, the pharaceuticals giant Servier rejected the deaths estimate describing it as 'theory founded on extrapolation.'

'Simply observing a valve problem in a diabetic person does not allow it to be attributed to medicinal treatment which remains a very rare cause,' it said in a statement yesterday.

However Irene Frachon, a doctor who this year published a study warning about the drug, said 'Mediator is responsible for a health disaster'.

She said the health authorities in France had been late in withdrawing the drug despite several alerts.

She estimated on in 2,000 who took the drug were at risk of serious ill-effects, some of whom would require open-heart surgery.

Afssaps pulled it from the market last November and the European Medicines Agency followed suit.

A similar drug also sold by Servier, the appetite-suppressor Isomeride, was withdrawn in 1997 after tests showed it raised the risk of high blood pressure, Afssaps said. That drug spawned several lawsuits against Servier.

A Servier spokesman confirmed that four patients had lodged complaints about Mediator since 2009.

A weight loss drug that has been taken by millions of French is likely to have been the cause of death of 500 people, the country's drug safety body announced on Tuesday, amid claims that health authorities long ignored calls for the drug to be banned.

Newly appointed Health minister Xavier Bertrand (right) and Junior minister for Health Nora Berra (left) give a press in Paris to sound warn patients Photo: AFP

By Henry Samuel in Paris 9:00PM GMT 16 Nov 2010

France's second-largest pharmaceutical group was yesterday at the heart of a spiralling health scandal over Mediator, a drug initially reserved for obese people with diabetes that became a popular appetite suppressor.

Afssaps, the drug safety body, yesterday said expert epidemiologists believed Mediator, made by Servier, had been lethal for at least 500 people and had caused 3,500 others to be admitted to hospital since its launch in 1976.

Some 300,000 people were taking the drug when Afssaps pulled it from the market last November, saying it had little effect on diabetes and might lead to a dangerous thickening of heart valves. The European Medicines Agency followed suit.

Diabetes patient tests his blood sugar. (istockphoto)

(CBS) For more than 40 years, the drug Mediator was used to treat diabetes and obesity in Europe, but now French health officials are saying it may have killed hundreds and offered almost no benefit to patients.

And those who used it from 2006 to 2009, before it was banned, are being asked to see their doctors to check for possible heart valve problems.

The French health products safety agency says at least 5 million people took the drug since 1976. They believe the medication is linked to the deaths of about 500 people.

Mediator, also known as benfluorex, is not the only diabetes drug to come under fire. In September, European regulators pulled the popular Type 2 diabetes drug Avandia off the shelves for fears it is linked to heart attacks. In America, the FDA voted to keep Avandia on the market but only as a medicine of last resort.

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