Benefits of Diane 35 and generics outweigh risks in specific patient group, says EMA unit; other actions

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefits of Diane 35 (cyproterone acetate 2mg, ethinylestradiol 35mcg) and its generics outweigh the risks, provided that several measures are taken to minimize the risk of thromboembolism (formation of blood clots in the veins and arteries).

These medicines should be used solely in the treatment of moderate to severe acne related to androgen-sensitivity and/or hirsutism (excessive unwanted growth of hair) in women of reproductive age. Furthermore, Diane 35, the brand of German drug major Bayer’s (BAYN: DE) product, should only be used for the treatment of acne when alternative treatments, such as topical therapy and oral antibiotic treatment, have failed. French drug regulators – who instigated the EMA review - recently removed Diane 35 from the domestic market (The Pharma Letter, February 1)

Since Diane 35 and its generics are hormonal contraceptives, women should not take these medicines in combination with other hormonal contraceptives. Concomitant use of Diane 35 and its generics with another hormonal contraceptive will expose women to a higher dose of estrogen and increase the risk of thromboembolism. The PRAC recommendation will now be considered by the Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh).