EMA announces restrictions to cyproterone use due to meningioma risk

Following a review, the European Medicines Agency‘s (EMA’s) safety committee has recommended that medicines with daily doses of 10mg or more 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. Once higher doses have started working, the dose should be gradually reduced to the lowest effective dose. 

The medicines should only be used for reduction of sex drive in sexual deviations in men when other treatment options are not suitable, the EMA has also announced. However, there is no change in use of the medicines in men for prostate cancer.

The decision has come after a review of the risk of the rare tumour meningioma with cyproterone. According to the regulatory body, this side effect is rare: it may affect between one and 10 in 10,000 people, depending on the dose and duration of treatment. The risk rises with increasing cumulative doses (the total amount of medicine a patient has taken over time).

Available data do not indicate a risk for low-dose cyproterone medicines containing 1 or 2mg of cyproterone in combination with ethinylestradiol or estradiol valerate and used for acne, hirsutism, contraception or hormone replacement therapy (HRT). However, as a precaution, the drug should not be used in patients who have or have had a meningioma. This restriction is already in place for the higher dose medicines.

The EMA says that doctors should monitor patients for symptoms of meningioma, which can include changes in vision, hearing loss or ringing in the ears, loss of smell, headaches, memory loss, seizures or weakness in arms and legs. If a patient is diagnosed with meningioma, treatment with cyproterone medicines must be stopped permanently.

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