French health authorities sounded an alert Tuesday to patients who took a diabetes drug believed to have killed 500 people over three decades in France before it was banned last year.
Drug safety body Afssaps urged patients who used Mediator, a drug for overweight people with diabetes that was also used as an appetite suppressant, to see their doctors if they had taken it for more than three months."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, Afssaps said in a statement.
The drug was banned in 2009 after being linked to heart valve damage. Five million patients were treated with medicines containing benfluorex, Afssaps estimated.Drug safety body Afssaps urged patients who used Mediator, a drug for overweight people with diabetes that was also used as an appetite suppressant, to see their doctors if they had taken it for more than three months."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, Afssaps said in a statement.
The company that sold it, pharmaceuticals firm Servier, rejected the 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 on Tuesday.
Afssaps director Jean Marimbert said at a news conference that anyone who had taken Mediator for more than three months should see a doctor.
"It is particularly important if the person took Mediator for three months or more since January 2006," he said.
Irene Frachon, a doctor who this year published a study warning about Mediator, said "Mediator is responsible for a health
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