Following a review of effect and risk of blood clots, the French authorities have decided to remove cyproterone/oestrogen-containing medicines* from the market within three months.
The French authorities have also announced that it will ask the Pharmacovigilance Risk Assessment Committee (PRAC) to review the medicine's safety. The medicine has been authorised for many years and is used throughout Europe, and just like contraceptive pills, it carries a risk of blood clots, which has been well known for many years and is described in the product information.
The French authorities' announcement will have no immediate consequences for the use of Diane® Mite and corresponding medicine in Denmark, but we will be following the pending EU review closely, and the outcome will be binding for Denmark.
In 2012, there were altogether 19,120 users of cyproterone/oestrogen-containing medicines in Denmark. Consumption has been stable over the past couple of years.
In Denmark, Diane® Mite, etc. is authoristed for the treatment of women with severe acne, polycystic ovary syndrome (ovarian cysts) and other diseases where antiandrogen therapy (discomfort caused by excessive levels of male hormones) is indicated.
Even though the medicine also works as a contraceptive, it should not be used for this purpose only.
Until the results of the EU review become available, we advise women who are treated with this medicine not to stop taking the medicine, but to discus their treatment at the next doctor's appointment.
EMA press release for diane35
* As at January 2013, the following products with the combination of cyproterone acetate (2 mg) and ethinylestradiol (0.035 mg) were available on the Danish market. Diane®mite, Dianova Mite, Feminil® mite, Vreya®, Zyrona and Cyproteronacetat/ethinylestradiol "ratiopharm".