European Medicines Agency issues restrictions on cyproterone medicines


  • Dawn O'Shea
  • Univadis Medical News
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The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended that medicines with daily doses of ≥10 mg of cyproterone should only be used for androgen-dependent conditions such as hirsutism, alopecia, acne and seborrhoea once other treatment options, including treatment with lower doses, have failed.

The PRAC advises that these medicines should only be used for reduction of sex drive in sexual deviations in men when other treatments are not suitable. There is no change in the use of these medicines for prostate cancer.

The recommendations follow a safety review which showed that meningioma occurs in 1-10 people in 10,000, depending on dose and duration of treatment. The risk increases with increasing cumulative doses.

Available data do not indicate a risk with low-dose (1-2 mg) cyproterone medicines in combination with ethinyloestradiol or oestradiol valerate and used for acne, hirsutism, contraception, or hormone replacement therapy. However, as a precaution, the PRAC recommends that they should not be used in people who have or have had a meningioma.

As part of ongoing surveillance, companies marketing medicines containing ≥10 mg of cyproterone are required to carry out a study to assess doctors’ awareness of the risk of meningioma and how to avoid it.