European Medicines Agency starts safety review of Diane 35 (cyproterone acetate and ethinylestradiol) and its generics

Source: European Medicines Agency (EMA) Area: News The European Medicines Agency (EMA)'s Pharmacovigilance Risk Assessment Committee (PRAC) has formally started a safety review of Diane 35 (cyproterone acetate 2mg, ethinylestradiol 35mcg) and its generics.   As reported previously on NeLM, this review has been initiated at the request of the French medicines regulatory agency (ANSM), following the announcement of its plan to suspend the marketing authorisations for Diane 35 and its generics for acne treatment in France over the next three months (see link below). These medicines are widely used across Europe; however their authorised uses differ between Member States. In France, they are only authorised for the treatment of acne, but ANSM has noted wide-spread off-label use as a contraceptive.   The ANSM is taking this action as a result of a review of known data, including reports of venous and arterial thromboembolism recorded in association with Diane 35 and its generics over a period of more than 20 years. ...
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news