EMA’s PRAC Recommends Restricted Use of Cyproterone

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended that the use of cyproterone be restricted as a result of the potential risk of meningioma.

According to a Feb. 14, 2020 press release, the recommendations include medicines with daily doses of 10 mg or more of cyproterone, which should be restricted for use in androgen-dependent conditions once other treatment options have failed. Additionally, PRAC recommends that cyproterone medicines should only be used for the reduction of sex drive in sexual deviations in men when other treatment options are not suitable. There was no change to the use of medicines with cyproterone for men with prostate cancer.

These recommendations have been issued as a result of a review on the potential risk of the rare tumor meningioma with cyproterone. The risk is considered small, potentially only affecting between 1 and 10 people in 10,000, and is dependent on the dose and duration of treatment. However, the risk can increase with cumulative doses.

From the available data, it has been discerned that there is no risk indicated with low-dose cyproterone medicines-those containing 1 or 2 mg cyproterone-although physicians have been recommended to monitor patients for symptoms of meningioma. If there is a diagnosis of meningioma, then it is recommended that treatment with cyproterone medicines is stopped immediately.

Companies marketing medicines that contain 10 mg of cyproterone or more are required to perform a study to assess doctors’ awareness of meningioma risk and how to avoid it as part of the ongoing surveillance of medicines’ safety.

Source: EMA