Diane 35™ and its generics are widely used across Europe but their authorised uses differ between Member States. In the UK, Dianette™ is licensed for the treatment of severe acne and moderately severe hirsutism. Although it also acts as a contraceptive it is not recommended for this purpose.
A Europe -wide review of these medicines was initiated at the request of the French medicines regulatory agency (ANSM), following a review by the agency which highlighted serious thromboembolic events and extensive off-label use of these medicines as a contraceptive only.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed all the available data and has made the following recommendations:
• These medicines should be used solely in the treatment of moderate to severe acne related to androgen-sensitivity and/or hirsutism in women of reproductive age.
• Diane 35 should only be used for the treatment of acne when alternative treatments, such as topical therapy and oral antibiotic treatment, have failed.
• 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.
• Efforts should be made to raise awareness of the risks, signs and symptoms of thromboembolism, to allow for timely diagnosis and appropriate treatment. This includes educational materials for 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.
• Further pharmacovigilance activities, including prospective drug- utilisation studies to assess future prescription patterns following the above-mentioned changes to the product information, as well as a post-approval safety study to assess the effectiveness of the risk- minimisation measures.
The PRAC recommendation will now be considered by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) which is considered a first step towards a common EU approach. However, following the PRAC review, the French ANSM has announced its decision to suspend the marketing authorisations of these medicines in France.
The MHRA have issued a response to the PRAC review advising that if women are concerned about their treatment they should discuss this with their GP.