Regulatory Focus™ > News Articles > Safety of Controversial Drug Affirmed by EU Regulators as France Falls in Line

Safety of Controversial Drug Affirmed by EU Regulators as France Falls in Line

Posted 31 May 2013 | By Louise Zornoza

After months of debate, the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) has endorsed by an overwhelming 26:1 vote the recommendation of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics outweigh the risks, provided that several measures are taken minimize  the risk of blood clots.  

Diane 35 reduces acne by regulating hormones and blocking ovulation, and is often prescribed off-label as a contraceptive.

The review of Diane 35 and its generics was triggered earlier this year by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), following its decision to suspend the drugs in France within three months. The French decision followed a national review of the drugs which highlighted serious thromboembolic events and extensive off-label use of these medicines as a contraceptive only. France was the only EU country where sales of the treatment were suspended.

The recommendations of CMDh will be sent to the European Commission, which will adopt a legally binding decision in the coming weeks. ANSM said on Thursday that it would comply with the European Commission if it rules that the treatment is safe to use in some cases, but will keep sales of the drugs on hold until then.


EMA Endorsement of Diane 35

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