The French National Agency for Medicines and Health Products Safety (ANSM) announced today that it plans to suspend sales of an acne treatment used off-label as an oral contraceptive that is linked to at least 4 deaths from venous thromboembolism (VTE) over the last 25 years.
The acne drug in question is cyproterone acetate 2 mg, ethinylestradiol 35 mg (Diane 35, Bayer, and its generics). Diane 35 is approved in France only for treating acne, but several other countries in the European Union (EU) have approved it for treating acne in women who also want to use it as an oral contraceptive, according to the European Medicines Agency (EMA), which functions as a food and drug regulatory agency for the entire EU. In addition, clinicians widely prescribe Diane 35 as a contraceptive on an off-label basis.
The US Food and Drug Administration (FDA) has not approved the drug for use in the United States.
Today’s announcement by the French equivalent of the FDA followed a review of Diane 35 that concluded that the drug and its generic versions increase the risk for VTE. At the same time, Diane 35 is only moderately effective at treating acne, and clinicians can turn to alternative treatments, ANSM stated.