Methotrexate containing medicinal products

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status
European Commission final decision

Overview

New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases

On 22 August 2019 EMA recommended new measures to prevent serious and potentially fatal errors with the dosing of methotrexate for treating inflammatory diseases such as rheumatoid arthritis, psoriasis and Crohn’s disease. The recommendations result from a review of reports that patients are using methotrexate incorrectly despite previous measures to prevent errors.

For inflammatory conditions, methotrexate must be used just once a week. Using methotrexate more frequently than intended can result in serious side effects. The review found that the error in dosing frequency can occur at any step from prescribing the medicine to the patient taking it.

The new measures to prevent errors 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 will be provided in blister packs and not in bottles (or tubes). The measures were agreed after consultation with patients and healthcare professionals.

Key facts

About this medicine
Approved name
Methotrexate containing medicinal products
International non-proprietary name (INN) or common name
methotrexate
Associated names
  • Nordimet
  • Jylamvo
  • Ledertrexate
  • Maxtrex
  • Metex
  • Metoject
About this procedure
Current status
European Commission final decision
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.

Authorisation model
Centrally and nationally authorised products (mixed)
Decision making model
PRAC-CHMP-EC
Key dates and outcomes
Procedure start date
12/04/2018
PRAC recommendation date
11/07/2019
CHMP opinion/CMDh position date
22/08/2019
EC decision date
21/10/2019
Outcome
Risk minimisation measures

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Opinion provided by Committee for Medicinal Products for Human Use

  • List item

    Methotrexate Article-31 referral - Nordimet : EPAR - Product Information


    First published: 31/10/2019

  • List item

    Methotrexate Article-31 referral - Jylamvo : EPAR - Product Information (PDF/355.11 KB)


    First published: 31/10/2019

  • List item

    Methotrexate Article-31 referral - Annex IV (PDF/17.07 KB)


    First published: 31/10/2019

  • List item

    Methotrexate Article-31 referral - Annex II (PDF/48.08 KB)


    First published: 31/10/2019

  • List item

    Methotrexate Article-31 referral - Annex I (PDF/908.39 KB)


    First published: 31/10/2019

  • List item

    Methotrexate Article-31 referral - Annex III (PDF/37.96 KB)


    First published: 23/08/2019
    Last updated: 31/10/2019

  • List item

    Methotrexate Article-31 referral - New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases (PDF/123.06 KB)


    First published: 23/08/2019
    EMA/414775/2019

  • European Commission final decision

    Description of documents published

    Please note that some of the listed documents apply only to certain procedures.

    • Overview - lay-language summary of the stage of the procedure
    • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
    • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
    • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
    • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
    • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
    • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
    • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
    • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
    • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
    • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
    • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
    • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
    • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
    • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

    Note that older documents may have different titles.

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