The Combination of Ethinylestradiol/Cyproterone Acetate Is Temporarily Withdrawn from the Market in France. Is the Measure Justified?
March 2013
in “
The European Journal of Contraception & Reproductive Health Care
”
TLDR The paper suggests that France's suspension of Diane-35 was hasty and could cause treatment issues and unintended pregnancies, recommending a re-evaluation and better patient information.
In 2013, the French health regulator ANSM suspended the sale of DianeⓇ-35, a product containing cyproterone acetate and ethinylestradiol, due to concerns over thrombosis risks. This contraceptive, primarily licensed for acne treatment, was often used off-label for birth control. The European Medicine Agency criticized the lack of European consultation prior to the decision. The paper criticizes the hasty suspension and lack of communication with users, which could lead to treatment disruption and unintended pregnancies. The authors call for a re-evaluation of Diane-35's risk-benefit balance and proper patient counseling by French and European authorities.
