These medicines have been authorised at the level of individual Member States for many years. They are widely used across Europe. However, their authorised uses differ between Member States. In many countries they are authorised as a contraceptive in women with hormone-related conditions such as acne, hirsutism (excessive growth of hair on the face) and alopecia (loss of hair). In France, they are only authorised for the treatment of acne, but ANSM has noted wide-spread off-label use as a contraceptive.
The risk of venous thromboembolism with these medicines is low but well known, and warnings are included in their product information to alert patients and prescribers to the risks. European legislation requires that there is a coordinated European approach when a Member State takes regulatory action in relation to a medicine that is authorised in more than one country. Therefore, the PRAC will evaluate all available evidence on the benefits and risks of these medicines and give a recommendation on whether their marketing authorisations should remain as they are, be varied, suspended or revoked, in the interest of all patients in the European Union. It is expected that the PRAC will adopt a recommendation at its 13 - 16 May 2013 meeting.
Pending the outcome of the PRAC review, women who are currently taking Diane 35 or one of its generics are advised not to stop the medicine. If a woman has concerns, she can discuss them with her doctor.