EMA's PRAC urges curbs on cyproterone; acts on communications

14 February 2020

Following a review of the risk of meningioma (a rare tumor of the membranes covering the brain and spinal cord) in patients taking cyproterone, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that medicines containing 10mg 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.

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