The benefits of acne drug Diane 35 and its generic equivalents outweigh the risks, provided measures are taken to minimize thromboembolism risk, according to a recommendation today from a European Medicines Agency committee.
The drug (cyproterone acetate 2 mg, ethinylestradiol 35 mcg, Bayer HealthCare Pharmaceuticals) should be used only for treating “moderate to severe acne … in women of reproductive age,” the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) reported in a press release. Diane 35 was recommended solely as an acne treatment when other topical therapies and oral antibiotic treatments have failed, PRAC said.
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