The European Medicines Agency (EMA) announced on 11 July 2019 that its Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of medicines containing cyproterone, which are used for treating a range of conditions, including hirsutism, prostate cancer and acne, as well as in hormone replacement therapy.
The review will look into the risk of meningioma, a rare, usually non-malignant tumour, which can cause serious problems due to its location in the body.
A recent study in France suggested that the risk of meningioma, although very low, may be increased in people taking high doses of cyproterone for a long period.
The PRAC will now examine the available evidence and make recommendations on the use of cyproterone-containing medicines across the EU.
The risk of meningioma with cyproterone daily doses of 10 mg or more has been known since 2008 and information was included in the prescribing information for these medicines along with a warning that cyproterone should not be used in people who have or have had a meningioma tumour. However, there was no information at the time on the magnitude of the risk and how the risk could change with different doses.
A recent study in France has now suggested that the risk of meningioma, although still very low, may be greater in those taking high doses of cyproterone for a long period. The study also showed that after patients had stopped cyproterone treatment for at least one year, the risk of developing these tumours was much reduced but remained slightly higher than usual.
Due to their location in and around the brain and spinal cord, meningiomas can cause serious problems. The French medicines authority has therefore asked EMA to investigate this risk, taking into account all the latest data.
EMA's safety committee, PRAC, will now examine the available evidence and make recommendations as to whether the marketing authorisation for cyproterone-containing medicines should be amended across the EU.
More about the medicine
Cyproterone is an antiandrogen medicine. Medicines containing cyproterone are used to treat various androgen-dependent conditions such as hirsutism, alopecia, early puberty, amenorrhoea, acne and prostate cancer. They are also used in hormone replacement therapy. Cyproterone medicines contain either cyproterone alone or cyproterone at a lower dose in combination with an oestrogen.
Cyproterone has been authorised in the EU via national procedures since the 1970s and is available on prescription under various trade names (e.g. Androcur).
More about the procedure
The review of cyproterone-containing medicines has been initiated at the request of France, under Article 31 of Directive 2001/83/EC.
The review is being carried out by the PRAC, the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations. 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 a body representing EU Member States as well as Iceland, Liechtenstein and Norway. It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.