Pharmacy Daily | Diane 35 France suspension

THE French medicines agency has announced the suspension of marketing authorisation for Diane 35 (cyproterone acetate 2mg, ethinylestradiol 35 micrograms) and its generic equivalents. In France the drug is only approved for the treatment of acne, but it’s also available across other states in Europe for the treatment of acne in women who want to receive oral contraception as well as for the treatment of other skin conditions. The French medicines agency (ANSM) has suspended Diane 35 following a review of known data. ANSM said it considers that the medication carries a risk of thromboembolism, which has been well known for many years, while its “effectiveness in treating acne was only moderate and alternative treatments for acne are available”. The agency also noted that Diane 35 and its generics were widely used off-label as a contraceptive. ANSM is asking the European Medicines Agency to carry out a Europe-wide review of the drug. Pending this investigation, women who are currently taking Diane 35 or one of its generics are advised not to stop the medicine.

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