Brussels, 23/05/2013 (Agence Europe) - On 21 May, the French national agency for safety of medicines (ANSM) decided to suspend the marketing authorisation for the Diane 35 contraceptive pill, despite the contrary recommendation from the European Medicines Agency (EMA). The latter considers that the “benefits of Diane 35 and its generics compensate for the risks to certain kinds of patients” and therefore this kind of medicine should not be withdrawn from the European market. The Diane 35 pill has been authorised in all member states, apart from Cyprus. In France, it was authorised as an anti-acne treatment but in three quarters of all cases it remains a prescribed means of contraception.
In a press release on 17 May, the Pharmacovigilance Risk Assessment Committee (PRAC) at EMA concluded the positive benefits of Diane 35 and its generics, “provided a number of measures are taken to minimise the risk of thromboembolism”. It is therefore recommending “new contraindications and warnings to patients and healthcare professionals” and says that “efforts should be made to raise awareness of the risks, signs and symptoms of thromboembolism, to allow for timely diagnosis and appropriate treatment”. The European agency adds that “Diane 35 and its generics can be used in the treatment of moderate to severe acne…or hirsutism (excessive unwanted growth of hair) in women of reproductive age”. It should be noted that EMA has not given a recommendation on the use of Diane 35 as a means of contraception and that the Bayer laboratory has only obtained marketing authorisation for its use as an anti-acne or anti-hirsute treatment. It notes, however, that Diane 35 has contraceptive pill properties and that this should, therefore, not be used in combination with any other hormonal contraceptive because combining Diane 35 with another hormonal contraceptive exposes women to high oestrogen levels, which increases the risks of thromboembolism. EMA's recommendations will be examined on 27 and 29 May by the Coordination Group for Mutual Recognition and Decentralised Procedures - medicines for human use (CMDh), a European body representing national medicines agencies. (IL/transl.fl)