The European Medicines Agency (EMA) has initiated a safety review of medicines containing the anti-androgen cyproterone.
While the risk of meningioma with cyproterone daily doses of 10 mg or more is well known, the new review follows a recent French study which suggests that the risk is greater in those taking higher doses of cyproterone for a long period. The study also showed that the risk was reduced after at least one year of ceasing treatment but remained higher than in the general population.
The French medicines authority has asked the EMA to re-examine the risk of meningioma with cyproterone-containing medicines, taking into account the latest data, and to make recommendations as to whether the marketing authorisation should be amended.
The review is being carried out by the EMA Pharmacovigilance Risk Assessment Committee (PRAC) and is expected to continue until at least November 2019. As cyproterone-containing medicines are all authorised nationally, the PRAC recommendations will be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which will adopt a position. The CMDh is the body responsible for ensuring harmonised safety standards for medicines across EU Member States, Iceland, Liechtenstein and Norway.