PARIS – French health officials said Tuesday the now-banned diabetes and weight loss drug Mediator may have been linked to the deaths of about 500 people in the 33 years it was on the market.
France’s health products safety agency has advised those who used the drug from 2006 to 2009 to see their doctor to check for possible heart valve problems.
The agency said Tuesday that about 5 million people used Mediator — the brand name for benfluorex in France — from 1976 until it was pulled off the market in 2009.
The European Medicines Agency said last year that it decided to remove benfluorex from the market because it had little effect on diabetes and might lead to a dangerous thickening of heart valves.
In September, European regulators pulled blockbuster diabetes drug Avandia off the market because of alleged links to heart attacks.
Benfluorex, used especially to treat weight problems among diabetics, underwent various tests over time, but it was only in 2006 that a confirmed case of heart valve problems related to its use was reported, the health safety agency said.
A complementary study was carried out last summer to determine what impact benfluorex had on patients who took the drug in 2006. It followed their hospitalizations and deaths linked to heart valve problems until June of 2010.
“On the basis of results, the analysis by epidemiologists believe that around 500 deaths may be attributable to benfluorex among all users of the medication since it went on the market,” the health products safety agency said.
The drugmaker, Servier, which has carried out its own tests, said the results were an “extrapolation.”
“The Servier Research Group underscores that these figures are hypotheses founded on extrapolations,” the drugmaker said in a statement
Heart valve problems naturally affect some 2.5 percent of the population, a figure that increases with age and the presence of diabetes, Servier said. It argued that the test does not allow one to blame all valve problems on the medication.
Servier, however, counseled patients to discuss the issue with their doctors as “a precaution.”
(This version CORRECTS spelling of benfluorex throughout.)
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