The European Medicines Agency (EMA) has suggested that medicines comprising a combination of dienogest 2 mg and ethinylestradiol 0.03 mg can remain to be used to treat acne when proper treatments applied to the skin or antibiotics taken by mouth have not worked. However, these medicines, which are also permitted as hormonal contraceptives, should only be used in women who choose oral contraception.
Having evaluated the existing data on the effectiveness of the combination in the treatment of acne, EMA’s Committee for Medicinal Products for Human Use (CHMP) determined that there is adequate proof to sustenance its use in moderate acne. Regarding the threat of side effects, the CHMP measured that the available data do not raise any new safety concern. The known risk of venous thromboembolism (VTE or blood clots in veins), which can occur with all combined hormonal contraceptives, is considered low. However, the data on the risk with dienogest/ethinylestradiol are not adequate to assess how it compares with other contraceptives and further data are still awaited.
As the detected benefits of dienogest/ethinylestradiol in the treatment of acne, the potential risk of VTE and the nature of the disease, the CHMP concluded that this combination should only be used after certain other treatments have failed, and only when oral contraception is chosen. The CHMP also recommended that women should be evaluated by their doctor 3 to 6 months after starting treatment and periodically subsequently to review the need for continuation of treatment.
27th Jan 2017
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/01/news_detail_002685.jsp&mid=WC0b01ac058004d5c1