Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2020

PRAC recommends restrictions in use of cyproterone due to meningioma risk

Following a review of the risk of meningioma (a rare tumour of the membranes covering the brain and spinal cord) in patients taking cyproterone, EMA's safety committee (PRAC) has recommended that medicines containing 10 mg 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.

There is no evidence of a risk for low-dose products containing cyproterone in combination with ethinylestradiol or estradiol valerate. However, as a precaution, these medicines should not be used in people who have or have had a meningioma.

More information is available below.

Direct healthcare professional communications to be regularly published on the EMA website

As of February 2020, EMA will publish on its website direct healthcare professional communications (DHPCs) agreed at European Union (EU) level by the PRAC, EMA's human medicines committee (CHMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).

DHPCs are important communications that are sent directly to healthcare professionals by marketing authorisation holders or a competent authority to inform them of new safety information about a medicine, such as:

  • a suspension, withdrawal or revocation of a marketing authorisation for safety reasons;
  • an important change in the product information, for example a restriction of indication, a new contraindication or a change in the recommended dose;
  • a medicine supply shortage;
  • a quality problem with a medicine.

A competent authority may disseminate or request the marketing authorisation holder to share a DHPC whenever this communication can benefit public health.

DHPCs will be published on the EMA website at the time of national dissemination. The new webpage also includes links to national registers of DHPCs.

More information on DHPCs is available in the  the guideline on good pharmacovigilance practices (GVP) Module XV - Safety communication

To read more Press Release articles, click here.