Flash VIG news: reassessment of risk of meningioma on cyproterone

The European Medicines Agency (EMA) is reassessing the risk of meningioma on medicines based on cyproterone, a risk that has long been known to medical professionals. A French study suggests that the risk of meningioma, even though small, can be greater in women who have taken high doses of cyproterone over long periods of time.

The risk of meningioma at daily doses of 10 mg or more of cyproterone has been known for many years. Information about the risk and a warning for people who have or have had a meningioma not to use cyproterone is provided in the summary of product characteristics (SPC) and the patient information leaflets (PIL) of medicines containing cyproterone.

A meningioma is a rare, usually benign tumour of the brain or spinal cord membranes. Even though a meningioma is usually benign, it can cause serious problems because meningiomas occur in and around the brain and spinal cord.

The EMA is re-investigating the connection between cyproterone and meningiomas. A recent study in France suggests that the risk of meningioma, even though small, can be greater in women who have taken high doses of cyproterone over long periods of time. The study also shows that the risk is reduced if the treatment with cyproterone is discontinued. Until the publication of these results, there was no information about the scope of the risk or about how the risk changes with the dose.

Medicines containing cyproterone are used to treat various androgen-dependent conditions:

  • hirsutism (excessive hair growth),
  • alopecia (hair loss),
  • early onset puberty,
  • amenorrhea (absence of menstruation),
  • acne,
  • prostate cancer.

These medicines are also used for hormone replacement therapy.

These include the following medicines:

  • with only cyproterone, in Belgium ANDROCURÒ with 10 or 50 mg cyproterone;
  • with cyproterone in a lower dose in combination with oestrogens, in Belgium CLAUDIAÒ, DAPHNEÒ, DAPHNE CONTINUÒ, DIANE-35Ò and ELISAMYLANÒ, with 2 mg of cyproterone and CLIMENÒ, hormone replacement therapy with 1 mg of cyproterone.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA is examining the available proof and formulating recommendations on the possibility of changing the marketing authorizations for medicines containing cyproterone in the entire European Union.

The FAMHP is following this European procedure carefully and will communicate the conclusions of the reassessment when they are available.

Last updated on
18/07/2019