EMA committee recommends restrictions in use of cyproterone due to meningioma risk
Following a review of the risk of meningioma (a rare tumour of the membranes covering the brain and spinal cord) in patients taking cyproterone, EMA’s safety committee (PRAC) has recommended that medicines containing 10 mg or more of cyproterone should only be used for hirsutism (excessive hair growth), androgenic alopecia (hair loss), acne and seborrhoea (excessively oily skin) once other treatment options, including treatment with lower doses, have failed.
Additionally, the medicines should only be used for reduction of sex drive in sexual deviations in men when other treatment options are not suitable.
The review found that the risk of meningioma increases when the total amount of medicine a patient has taken over time is increasing. Overall, this side effect is rare: it may affect between 1 and 10 in 10,000 people, depending on the dose and duration of treatment.
There is no evidence of a risk for low-dose products containing cyproterone in combination with ethinylestradiol or estradiol valerate. However, as a precaution, these medicines should not be used in people who have or have had a meningioma.