Brussels, 31/07/2013 (Agence Europe) - On 30 July, following the recommendation made by the European Medicines Agency (EMA), the European Commission confirmed that sales of the Bayer acne pill Diane 35 product would now be obligatory in France. In an effort to provide assurances to France, the Commission, however, decided to restrict the use of this medicine (often prescribed as a contraceptive and sometimes used for treating alopecia - hair loss - and to require better information about its side-effects, particularly the risks of thrombosis. The French medicines agency (Agence française du médicament ANSM) which decided to suspend sales of Diane 35 has indicated that it will comply with the European recommendation. It will, however, be for the Bayer pharmaceutical group to decide whether to resume sales in France. Bayer Santé, the French subsidiary of the German group, however, welcomed the Commission decision and stated that it was seeking to work closely with the ANSM “to reintroduce Diane 35 on the French market in the required conditions, following European arbitration”.
The debate on the potential danger of the third-generation pill began in France after a complaint was filed in December 2012 by a young woman who had suffered a stroke, which she said was due to using this contraceptive pill. Following other complaints, the ANSM decided, on 21 May 2013, to suspend authorisation to sell Diane 35 on the French market, despite a contrary recommendation made by the European Medicines Agency (EMA). The French agency deemed that this medicine, for which sales are only allowed to treat acne, but which has also been used as a means of contraception, increased the risk of stoker among women. The Regulatory Procedure with Scrutiny Committee (PRAC) at the EMA, however, stated that “the benefits of Diane 35 and its generics compensated for the risks to certain categories of patients”. It did, nonetheless, recommend the introduction of certain measures to reduce the risks of suffering from thrombosis (see EUROPE 10851). It was left to the Commission to come to a decision on the matter and it chose to support the recommendation made by the EMA. On the basis of the PRAC's conclusions, the Commission decided that “the benefits of the pill outweighed any risks” but it also issued a number of reservations. 1) For treating acne, Diane 35 should only be used “after the failure of a topical treatment or systemic antibiotic treatments”. Indications should also be provided about side effects for patients who have a previous history or hereditary predisposition to deep vein thrombosis. 2) As a means of contraception, its use is “concomitant with other hormonal contraceptives, together with possible side-effects indicated”. 3) Its used for treating alopecia must be prescription-based. The Commission also called for a revision of the consumer and health professionals' notes for use and marketing authorisations will also have to provide a “comprehensive three-monthly risk management plan”. (IL/transl.fl)