The MHRA has issued the new advice following findings of a cumulative dose-dependent association between cyproterone acetate and the known increased risk of meningioma.
The findings come from a French epidemiological cohort study, which included a population of 253,777 women taking 50–100mg cyproterone acetate. The study showed that patients with a cumulative exposure to 36–60g cyproterone acetate were at an approximately 11-times higher risk of meningioma than patients with cumulative exposures of <3g. A 36g cumulative exposure equates to a daily dose of 100mg cyproterone for 1 year.
Further informationView cyproterone drug records
The European Medicines Agency (EMA) reviewed the data and concluded that 50mg or 100mg of cyproterone acetate should be used only when alternative treatments or interventions are unavailable or considered inappropriate, for all indications except prostate cancer.
Low-dose cyproterone acetate combined with ethinylestradiol (co-cyprindiol) has not been associated with an increased risk of meningioma. However, since the risk of meningioma increases with cumulative doses of cyproterone, co-cyprindiol is now contraindicated in patients with a history of or existing meningioma. This contraindication is already in place for higher dose products.
Healthcare professionals are advised to be vigilant for signs and symptoms of meningioma in patients taking cyproterone; these include changes in vision, loss of hearing, tinnitus, loss of smell, headaches that worsen with time, memory loss, seizures, or weakness in extremities. Treatment must be permanently stopped if a meningioma is diagnosed.
Cyproterone should only be used for control of libido in severe hypersexuality or paraphilias in adult men when other interventions are considered inappropriate.