Brussels orders France to lift ban on drug accused of blood clot risk
Issued on: Modified:
The European Commission has ordered France to lift a ban on the sale Diane 35, a hormonal acne treatment that is often prescribed as a contraceptive, which has been accused of causing deadly blood clots.
The commission on Tuesday ruled that the pill, produced by German pharmaceutical giant Bayer, is not harmful.
That means that it can be sold in France, health spokesperson Frédéric Vincent declared.
France’s health watchdog, the ANSM, in January announced that the sale of Diane 35 and generic drugs like it would be banned within three months because of the risk of thrombosis and pulmonary embolism.
The ANSM told doctors not to prescribe third- and fourth-generation contraceptive pills as a first choice because research had linked it to 2,500 cases of potentially fatal blood clots.
In December 2012 Marion Larat, who had suffered a cerebrovascular accident allegedly caused by a third-generation pill, sued Bayer, bringing the alleged dangers into the public eye.
But in May the European body that brings together member-states’ health regulators criticised the French ban.
Philippe Courtois, a lawyer representing 16 alleged victims of Diane 35, believes the EU decision confirms the drug should never have been prescribed as a contraceptive.
"The decision from Brussels obliges France to return the product to the market, but only to treat acne," he told RFI on Wednesday. "It underlines that a situation was allowed to persist for years in which a product was prescribed as a contraceptive when it should not have been."
The decision doesnot affect the case against Bayer and the French health authorities, Courtois claimed.
Daily newsletterReceive essential international news every morningSubscribe