The French medicines agency is planning to suspend marketing authorisation for Diane 35 and generics used in the treatment of acne in France within three months.
Diane 35 (cyproterone acetate 2mg, ethinylestradiol 35 micrograms) and its generics are only authorised for the treatment of acne in France.
The medicines are also authorised for acne treatment in women who wish to take oral contraception in addition to treatment of other skin conditions in a number of other Member States.
The French medicines agency (ANSM) has reviewed known data and concluded that Diane 35 and its generics are associated with risk of thromboembolism whereas their effectiveness in acne treatment was moderate and other alternatives are available.
ANSM also noted that the medicines are being used off-label as a contraceptive.
France will ask the European Medicines Agency to review Diane 35 and its generics across the Europe to evaluate the benefits and risks associated with the drugs by Pharmacovigilance Risk Assessment Committee (PRAC).
After the evaluation, the European Medicines Agency is expected to recommend suspension of the marketing authorisations in the EU.
Even though Member States can take independent action with regard to a suspension of the marketing authorisation of a medicine, European legislation necessitates a coordinated European approach in such instances.