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

14 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 Guideline on good pharmacovigilance practices: Module XV – Safety communication (Rev. 1)

Agenda

Agenda - PRAC draft agenda of meeting 10-13 February 2020

Draft Reference Number: EMA/PRAC/20444/2020

PRAC statistics: February 2020

PRAC statistics: February 2020

Glossary:

• Safety signal assessments. A safety signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under Signal management.
• Periodic safety update reports, abbreviated as PSURs, are reports prepared by the marketing authorisation holder to describe the worldwide safety experience with a medicine in a defined period after its authorisation. PSURs for medicinal products that contain the same active substance or the same combination of active substances, but have different marketing authorisations and are authorised in different EU Member States, are jointly assessed in a single assessment procedure. More information can be found under Periodic safety update reports: questions and answers.
• Risk management plans, abbreviated as RMPs, are detailed descriptions of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies are required to submit an RMP to EMA when applying for a marketing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. More information is available under Risk-management plans.
• Post-authorisation safety studies, abbreviated as PASSs, are studies carried out after a medicine has been authorised to obtain further information on its safety, or to measure the effectiveness of risk-management measures. The PRAC assesses the protocols (aspects related to the organisation of a study) and the results of PASSs. More information can be found under Post-authorisation safety studies (PASS).
• Referrals are procedures used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral related to safety of medicines, the PRAC is requested by a Member State or the European Commission to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. More information can be found under Referral procedures.

Ongoing referrals

Procedure	Status	Update
Article-20 procedure: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products	Under evaluation	PRAC continued its assessment.
Article-31 procedure: Leuprorelin-containing depot medicinal products	Under evaluation	PRAC continued its assessment.
Article-20 procedure: Picato	Under evaluation	PRAC continued its assessment