The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has concluded that the benefits of Bayer's acne drug Diane 35 and its generics outweigh the risks, "provided that several measures are taken to minimise the risk of thromboembolism".
One of the key issues around Diane 35 (cyproterone/ethinylestradiol) is that it is also prescribed in some countries off-label as a contraceptive. A Europe-wide review was initiated at the request of the French medicines regulatory agency (ANSM), which suspended the marketing authorisations for Diane 35 and its generics in France.
In January, the EMA issued a report saying there was no new evidence of any safety risk from third- and fourth-generation contraceptives pills and then initiated a PRAC review. The committee has concluded that Diane 35 and its generics should be used solely in the treatment of moderate to severe acne related to androgen-sensitivity and/or hirsutism in women of reproductive age.
Furthermore, Diane 35 should only be used for acne when alternative treatments, such as topical therapy and oral antibiotics, have failed. The PRAC added that women should not take these medicines in combination with other hormonal contraceptives as it will expose them to a higher dose of oestrogen and increase the risk of thromboembolism.
The EMA announcement was followed by a similar statement from Health Canada which said that its safety review of Diane 35 supports current labelling and use.