Warnings Against Diabetes Drug Mediator Ignored for 11 Years
Diabetes treatment drug Mediator, also used as an appetite suppressant, has been left in the market for eleven years despite alerts of its dangers since 1998.
Le Figaro reports that the French Drug Agency (L'Agence du médicament) has been warned about the health dangers of Mediator in 1998. Yet, the group has only been removed from the market in 2009. The newspaper on Friday has published on a letter to the agency, dated 21 September 1998, by three professors warning the agency about the serious health dangers of this diabetes treatment drug.
"It seems useful to alert the Agency of Medicine about the uncontrolled use of amphetamine product.," reads the letter. The professors have noted the irony of free prescription of Mediator, while amphetamine group of drugs are strictly controlled. They end the letter by warning against the indiscriminate use of the Mediator.
This warning, clearly formulated by renowned professors, has not been effectively followed by the drug agency. No action was taken until 2009, when in November of that year Mediator was removed from the market.
The history of the withdrawal is paradoxical in natural. It has been a subject of investigation in Italy since 1998. Eventually Italy removed the drug from its market in 2003. Spain also removed Mediator during the same year from its market.
The drug has been used by 5 million French since 1976. According to the French Agency for Safety of Health Products (AFSSAPS) it has caused 500 deaths in France since the commercialization by Servier Pharmaceutical.
It took ten years before a serious investigation was launched. Only eleven years later the drug was finally removed from the market.
Servier, in its defense, has justified keeping the drug in the market because of the small numbers of reported complications. Yet, those numbers were enough fro others to report a serious warning, Le Figaro concludes.