Oral contraceptives containing dienogest 2 mg and ethinylestradiol 0.03 mg may still be used to treat moderate acne in women, but only after other treatments have failed, given the drug's predictable risk for venous thromboembolism (VTE), European Union (EU) regulators said today.
In addition, this acne treatment is indicated only for women who choose oral contraception.
Dienogest/ethinylestradiol has been marketed as an oral contraceptive for years in EU nations under trade names such as Valette. In February 2016, before its Brexit vote, regulators in the United Kingdom asked the EU's European Medicines Agency (EMA) to evaluate the drug because they were not convinced that the benefits of treating acne with it outweighed the risk for VTE.
EMA's Committee for Medicinal Products for Human Use (CHMP) looked into the matter and concluded that there was enough evidence for the drug's continued use in treating moderate acne, and that "the available data do not raise any new safety concern." CHMP noted that all combined hormonal contraceptives pose a low risk for VTE. In the case of dienogest/ethinylestradiol, there was not enough evidence to accurately compare its VTE risk to that of other oral contraceptives. "Further data are still awaited," CHMP said.
In a cautionary move, CHMP recommended that clinicians prescribe the drug to treat a woman's acne only when topical treatments or oral antibiotics have not worked, "and only when oral contraception is chosen."
CHMP also recommended that women treated with dienogest/ethinylestradiol for acne be assessed for improvement 3 to 6 months after the start of therapy, and periodically afterward to determine if it is still needed.
In 2013, another EMA committee made a similar recommendation about oral contraceptives containing cyproterone acetate and ethinylestradiol (Diane 35) that are used to treat acne as well. EMA's Pharmacovigilance Risk Assessment Committee said that the physicians should prescribe the drugs for acne only when alternative treatments fail. In addition, the drugs should not be used in combination with other hormonal contraceptives lest women become exposed to a higher level of estrogen, increasing the VTE risk.
Today's CHMP opinion on dienogest/ethinylestradiol now goes to the European Commission, the EU's executive body, which will make a final decision.
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