Benefits of Diane 35 and its generics outweigh risks in certain patient groups

PRAC recommendation endorsed by CMDh

31-May-2013 - United Kingdom

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed by majority (26:1) 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 to minimise the risk of thromboembolism (formation of blood clots in blood vessels). 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) in women of reproductive age. Furthermore, Diane 35 and generics should only be used for the treatment of acne when alternative treatments, such as topical therapy and antibiotic treatment, have failed.

Since Diane 35 and its generics act as 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 oestrogen and increase the risk of thromboembolism.

The risk of thromboembolism occurring with these medicines is low and well known. However, to minimise this risk, further measures should be implemented in addition to the updated product information. These include providing educational materials to prescribers and patients highlighting the risks of thromboembolism, for example a prescriber checklist to ensure that the risks, together with the signs and symptoms, are discussed with the patient.

These recommendations have been endorsed by the CMDh, a body representing EU Member States. Because the CMDh took this position by majority it will now be sent to the European Commission, which will adopt a legally binding decision.

The review of Diane 35 and its generics was triggered by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), following its decision to suspend Diane 35 and its generics in France within three months. The French decision followed a national review of the medicine by ANSM. This review highlighted serious thromboembolic events and extensive off-label use of these medicines as a contraceptive only.

Despite the PRAC recommendation ANSM proceeded with the suspension of the marketing authorisation of these medicines in France. Once the European Commission has adopted its decision, all EU Member States where Diane 35 and its generics are authorised must follow it and ensure that all agreed risk minimisation measures, including changes to the information to prescribers and patients, are implemented.

https://www.bionity.com/en/news/143336/benefits-of-diane-35-and-its-generics-outweigh-risks-in-certain-patient-groups.html