Methotrexate containing medicinal products

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status:
Recommendation provided by Pharmacovigilance Risk Assessment Committee

Overview

PRAC recommends new measures to avoid dosing errors with methotrexate

EMA’s safety committee (PRAC) is recommending new measures to avoid dosing errors that have led to some patients incorrectly taking methotrexate-containing medicines daily instead of weekly.

The new measures 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).

Methotrexate is used for treating both inflammatory diseases and cancers. When used for inflammatory diseases, such as arthritis and psoriasis, it is taken once a week but for 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 risk of dosing errors with methotrexate-containing medicines is well known. However, despite several measures already in place, these errors continue to be reported.

The PRAC examined the available evidence and recommended additional measures to reduce dosing errors so that benefits of methotrexate-containing medicines continue to outweigh their risks. The measures were agreed after consultation with patients and healthcare professionals.

Measures to prevent dosing errors with methotrexate
  • Only doctors with expertise in using methotrexate-containing medicines to prescribe them.
  • Healthcare professionals to ensure that patients or carers are able to follow the once-weekly dosing schedule.
  • To avoid confusion, recommendations to split the dose should be deleted from the product information for the tablet formulation.
  • Packaging for all methotrexate-containing medicines for once-weekly use to include a prominent reminder of how the medicine should be used.
  • Patient card emphasising the weekly dosing for inflammatory diseases to be provided with oral medicines.
  • Healthcare professionals to be provided with educational materials for oral medicines and to counsel patients accordingly.

Tablets to be available in blister packs instead of bottles (or tubes) in order to help patients follow the once-weekly dosing.

The PRAC recommendations will now be sent to the Committee for Medicinal Products for Human Use (CHMP), which will adopt an opinion.

Healthcare professionals will be informed in writing of the above changes. Patients who have any concerns about their medicine in the meantime should discuss them with their doctor or pharmacist.

Key facts

About this medicine
Approved name
Methotrexate containing medicinal products
International non-proprietary name (INN) or common name

methotrexate

Associated names
  • Nordimet
  • Jylamvo
About this procedure
Current status
Recommendation provided by Pharmacovigilance Risk Assessment Committee
Reference number
EMEA/H/A-31/1463
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Decision making model
PRAC-CHMP-EC
Authorisation model
Centrally and nationally authorised products (mixed)
Key dates and outcomes
Procedure start date
12/04/2018
PRAC recommendation date
11/07/2019
Outcome
Risk minimisation measures

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Document description

  • Annex I - List of the medicines affected by the referral
  • Annex II - Scientific conclusions of the CHMP or CMDh
  • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
  • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
  • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
  • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
  • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
  • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
  • PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

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