Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2019

News 11/07/2019

PRAC starts review of meningioma risk with cyproterone medicines

EMA’s safety committee (PRAC) has started a review of medicines containing cyproterone, which are used for treating a range of conditions, including excessive hair growth, prostate cancer and acne, as well as in hormone replacement therapy.

The review will look into the risk of meningioma, a rare, usually non-malignant tumour of the membranes covering the brain and spinal cord, which can cause serious problems due to its location in the body.

A recent study in France suggested that the risk of meningioma, although very low, may be increased in people taking high doses of cyproterone for a long period.

The PRAC will now examine the available evidence and make recommendations on the use of cyproterone-containing medicines across the EU.

More information is available below.

PRAC recommends new measures to avoid dosing errors with methotrexate

The PRAC is recommending new measures to avoid dosing errors that have led to some patients incorrectly taking methotrexate-containing medicines daily instead of weekly.

Methotrexate is used to treat both inflammatory diseases and cancer. When used as an anti-inflammatory in the treatment of diseases such as arthritis and psoriasis, it is taken once a week. For the treatment of some types of cancer, a much higher dosage is needed and the medicine is taken more frequently. Mistakes in prescribing or dispensing methotrexate as well as misunderstandings of the dosing schedule have led to patients taking the medicine daily instead of weekly for inflammatory diseases, with serious consequences, including fatalities.

The PRAC examined the available evidence and recommended additional measures to reduce dosing errors. These include restricting who can prescribe these medicines, making warnings on the packaging more prominent and providing educational materials for patients and healthcare professionals. In addition, to help patients follow the once-weekly dosing, methotrexate tablets for weekly use will be provided in blister packs and not in bottles or tubes.

More information is available below.

PRAC statistics: July 2019


  • 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'.
  • 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.

Start of referral - Article-31 referral

Ongoing referrals




Article-31 procedure: Estradiol-containing (0.01% w/w) medicinal products for topical use

Under evaluation

PRAC adopted a list of outstanding issues

Article-31 procedure: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products

Under evaluation

PRAC adopted a list of outstanding issues

Article-20 procedure: Lemtrada

Under evaluation

PRAC adopted a list of outstanding issues

Article-31 procedure: :

Under evaluation

PRAC continued its assessment.
Article-20 procedure: Xeljanz Under evaluation PRAC continued its assessment

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