France warns of deadly diabetes drug
France's government Tuesday warned patients to see their doctor if they took a diabetes drug that is believed to have killed 500 people over three decades before it was banned a year ago.
The alert targets Mediator, a drug for overweight people with diabetes that was also used as an appetite suppressant until it was banned in November 2009 over fears it was linked to heart trouble.
"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," new Health Minister Xavier Bertrand told a news conference.
Drug safety body Afssaps said in a statement: "Analyses by expert epidemiologists estimate that about 500 deaths could be attributable to benfluorex," Mediator's active ingredient, since its launch in France in 1976.
The drug was banned in France, where millions of people took it, in 2009 after being linked to heart valve damage. It is also banned in the United States, Spain and Italy.
The company that sold it, pharmaceuticals firm Servier, rejected the Afssaps estimate as "theories founded on extrapolation". It said 2.5 percent of the population had valve trouble and age and diabetes heightened the risk.
"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 Tuesday.
Irene Frachon, a doctor who this year published a study warning about the drug, said "Mediator is responsible for a health disaster".
She added that there was no need to panic, however, estimating that one in 2,000 people who took the drug were at risk of serious ill-effects.
"The health authorities were late in withdrawing this drug despite several alerts" about threats it posed to the heart valves, Frachon told AFP on Tuesday.
"I know personally some of the victims and what they have suffered. Some of them have undergone open heart surgery and they have to take lots of medication," Frachon said, estimating 80 percent of those affected were women.
A similar drug also sold by Servier, the appetite-suppressor Isomeride, was withdrawn in 1997 after tests showed it raised the risk of high blood pressure, Afssaps said.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.
Afssaps added that 11 cases of valve damage in patients taking Isomeride were reported to drug safety authorities in France between 1997 and 2006.
That year also saw the first confirmed case of heart valve damage caused by benfluorex, in a woman who had to have a valve replaced after taking Mediator.
One patient who took the drug for two years for diabetes, Yvan Bakaric, 70, told AFP it made him lose 40 kilos and he thought he was going to die before a doctor took him off it.
"I was so thin and pale that people I knew didn't recognise me. I was sure I was going to die," he said, adding that he still suffers from fatigue and shortness of breath.
A Servier spokesman told AFP four patients had lodged complaints about Mediator since 2009 and that 500 deaths represented a tiny risk compared to the number of people who took the drug.
"But in terms of brand image, it's disagreeable," he added.
© 2010 AFP