BioCentury
ARTICLE | Clinical News

Diane 35 cyproterone/ethinylestradiol regulatory update

February 4, 2013 8:00 AM UTC

France's National Agency for the Safety of Medicines and Health Products (ANSM) announced it would suspend approval of Bayer's Diane 35 cyproterone/ethinylestradiol and its generic versions within 3 months following a review of data. EMA said ANSM considered the drugs are associated with an increased risk of venous thromboembolism "which has been well known for many years," but their effectiveness in treating acne is "only moderate" and alternative treatments are available. The drugs are used off label as an oral contraceptive. ...