Because of the thromboembolic risks, the Medicines Agency had decided to suspend this anti-acne drug used by 315,000 French women. Europe does another analysis.
“The benefit / risk ratio of Diane 35 and its generics is positive in acne,” said the Committee for the Evaluation of Pharmacovigilance Risks (PRAC) of the European Medicines Agency (EMA) on Friday. The decision contradicts that taken at the beginning of the year by the French health authorities.
The European re-evaluation of Diane 35 was initiated following a referral in January by the National Agency for the Safety of Medicines and Health Products. The ANSM indeed considered that the drug presented an unfavorable benefit / risk ratio in its only indication approved in France, the treatment of acne in women, and pointed out its wide use without marketing authorization (AMM), in contraception.
The Ansm was based at the time on new data published in 2011 by Lidegaard2 and which showed that “in women treated with Diane 35, the risk of venous thromboembolism is 4 times greater than that observed in untreated women”. The Agency had thus decided to suspend its MA from May 21, the time to leave other alternatives to users.
A point of view that does not share the PRAC which for its part rehabilitated the product. The Committee, however, reminds doctors of the correct use of Diane 35 to order, specifying that “this medication should only be used for the treatment of moderate or severe acne. […] and / or for the treatment of hirsutism, namely excessive unwanted hair growth, in women of childbearing age ”. The benefit / risk ratio therefore remains favorable even if, mentions the European committee, certain measures must be taken to “minimize the risks of thromboembolism. “
Regarding the use of this drug for contraceptive purposes, the EMA does not comment since its manufacturer has not obtained marketing authorization in France for this use. The EMA warns however on the risks of this practice by indicating that Diane 35 “must not especially be used in combination with another hormonal contraceptive”.
These recommendations will now be examined on May 27 and 29 by the Coordination Group for Mutual Recognition and Decentralized Procedures – Medicines for Human Use (CMDh), a European entity representing national medicines agencies.
The final decision will rest with the European Commission, the only institution empowered to settle this type of arbitration definitively. In the event of a favorable decision for Diane 35 on the part of the Commission, France would be obliged to end the suspension of anti-acne and its generics. In this case, it will be up to the German laboratory Bayer to choose whether or not to put back on the market these drugs which have fueled so many controversies. In 2012, it was estimated in France that approximately 315,000 women were treated with Diane 35.
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