Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 April 2018

13 April 2018

PRAC starts new referral on methotrexate

PRAC to review risk of dosing errors with methotrexate

The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of the risk of dosing errors with methotrexate medicines, used to treat cancers such as acute lymphoblastic leukaemia and various inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis and psoriatic arthritis.

When used for inflammatory diseases, methotrexate is taken once a week, whereas for some types of cancer, the dose is higher and the medicine is used more frequently. Mistakes have led to some patients incorrectly receiving a dose every day instead of every week, with serious consequences in some cases.

Although the risk of dosing errors with methotrexate has been recognised for many years and several measures are already in place in some countries in the European Union (EU) to reduce this risk, serious adverse events related to overdosing, including fatalities, still occur.

The Spanish Agency for Medicines and Health Products therefore asked the PRAC to further investigate the reasons why dosing errors continue to occur in order to identify and put in place measures to prevent them.

More information is provided below.

PRAC to further consider unmet medical needs for hydroxyethyl-starch (HES) solutions for infusion

Following the PRAC recommendation in January 2018 to suspend the marketing authorisations for HES solutions for infusion across the EU, the European Commission has requested that the committee further consider any possible unmet medical need that could result from the suspension, as well as the feasibility and likely effectiveness of additional risk minimisation measures.

The PRAC is now looking at these specific aspects and will discuss its recommendation at its May meeting. The PRAC's revised recommendation will then be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a final position.

More information is available in the summary record of the meeting of the Commission's Standing Committee on Medicinal Products for Human Use.

Agenda

Agenda - PRAC draft agenda of meeting 9-12 April 2018

Start of referral

Methotrexate containing medicinal products
Article-31 procedure: Methotrexate containing medicinal products Methotrexate Article-31 referral - Review started Methotrexate Article-31 referral - PRAC list of questions Methotrexate Article-31 referral - Annex I Methotrexate Article-31 referral - Notification

Ongoing referrals

Procedure	Status	Update
Article-20 procedure: Esmya	Under evaluation	PRAC continued its assessment and adopted a list of experts for an ad-hoc expert group meeting.
Article-31 referral: Quinolone- and fluoroquinolone-containing medicinal products	Under evaluation	PRAC continued its assessment.
Article-20 procedure: Xofigo	Under evaluation	PRAC continued its assessment.
Article-20 procedure: Zinbryta	Under evaluation	PRAC continued its assessment.