France: Diane 35 is officially withdrawn from sale

Publié le : 24 May 2013

 Following the decision of the National Agency for the Safety of Medicines (ANSM) last January, Diane 35 and its generics are no longer available in pharmacies in France as of Tuesday 21 May. The ANSM considered that the benefit/risk balance of this anti-acne pill widely prescribed as a contraceptive was unfavourable.          

However, on Friday 17 May 2013, the European Medicines Agency (EMA), which had been approached by the ANSM, did not come out in favour of a suspension of the authorisation to market this medicine, but nevertheless issued reserves. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) "recommends […] new counter-indications and warnings to be given to patients and health professionals to limit the risks of thrombosis," risks that the ANSM had highlighted. Moreover, the European Agency insisted on the fact that Diane 35 and its generics are “widely used as a contraceptive in the absence of acne, hence outside of the framework of the marketing authorisation.
The ANSM stated that it acknowledged this decision but pointed out that it is not definitive. Its statement reads: "the final decision will be taken by the European Commission. It is at this last stage that all the measures to ensure the safe use of these medicines can be implemented and applied to all the Member States, including France."

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