The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has investigated the safety of medicines containing cyproterone acetate and ethinylestradiol, which are used in the treatment of acne (Diane® Mite, etc.*). The Committee concludes that the benefits of these medicines outweigh the risks, provided they are used in specific patients and measures are taken to minimise the risk of blood clots.
Precautions for using Diane® Mite, etc.
- These medicines should be used solely in the treatment of moderate to severe acne related to androgen-sensitivity and/or hirsutism (excessive unwanted growth of hair) in women of reproductive age.
- The medicines should only be used for the treatment of acne when alternative treatments, such as topical therapy and oral antibiotic treatment, have failed.
- As the medicines are also birth-control pills (like contraceptive pills), women should not take these medicines in combination with other hormonal contraceptives as it would expose them to a higher dose of estrogen and increase the risk of blood clots.
The risk of blood clots is low and, like contraceptive pills, well known, which is described in the product information.
Why was the medicines' safety reviewed?
The European review was started at the request of French authorities after an investigation in France raised concern about the risk of blood clots and highlighted extensive off-label use of these medicines as a contraceptive only.
As a result of the review, the product information will be updated with harmonised warnings and recommendations for patients and doctors.
Please see the press release from EMA here: Benefits of Diane 35 and generics outweigh risks in specific patient group
* As at January 2013, the following products with the combination cyproterone acetate (2 mg) and ethinylestradiol (0.035 mg) were on the Danish market. Diane®mite, Dianova Mite, Feminil® mite, Vreya®, Zyrona and Cyproteronacetat/ethinylestradiol "ratiopharm".