- The safety committee of the European Medicines Agency (EMA) has recommended restricting products containing cyproterone with daily doses of ≥10 mg because of meningioma risk.
Why this matters
- In July 2019, the EMA's Pharmacovigilance Risk Assessment Committee initiated a safety review after a request from France based on results showing a cumulative dose-dependent association between cyproterone acetate and meningioma.
- The new guidance strengthens warnings introduced in 2009 about the risk for noncancerous meningeal tumors.
- EMA recommends use of products containing cyproterone ≥10 mg daily only when other options, including lower doses, have failed for treatment of androgen-dependent conditions such as hirsutism, alopecia, acne, and seborrhea.
- Once higher doses show effect, the dose should be gradually decreased to the lowest effective dose.
- Companies marketing these products must conduct a study to assess clinician awareness of meningioma risk and how to avoid it.
- Meningioma risk is low (1-10 per 10,000 population), and most cases have been reported after prolonged exposure to high cyproterone doses (≥25 mg daily).
- There is no change in the use of these products in the antiandrogen treatment of prostate cancer or for low-dose cyproterone in combination with estrogens for acne, hirsutism, contraception, or hormone replacement.