Flupirtine-containing medicinal products

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CMDh position
  • European Commission final decision
Current status:
Position provided by CMDh

Overview


Withdrawal of pain medicine flupirtine endorsed

Serious liver problems continued to be reported despite previous restrictions in use

The CMDh1 has endorsed EMA's recommendation to withdraw the marketing authorisation for the pain medicine flupirtine, because of the risk of serious liver injury. This means that the medicine will no longer be available.

The EMA recommendation was the outcome of a review of flupirtine medicines which was started because liver problems continued to be reported even after measures were introduced in 2013 to manage this risk. These measures had included limiting flupirtine use to no more than 2 weeks in patients with acute pain who could not use other painkillers, and carrying out weekly tests of liver function during treatment.

The review, carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), looked at the available data including studies evaluating whether the 2013 restrictions were followed in clinical practice. It also assessed cases of serious liver damage reported since the 2013 review.

The CMDh agreed with the PRAC conclusion that the restrictions introduced in 2013 have not been sufficiently followed, and cases of serious liver injury, including liver failure, still occurred. In addition, no further measures to increase adherence to the restrictions nor adequately reduce the risk of liver problems could be identified.

The CMDh therefore agreed that patients taking flupirtine-containing medicines continue to be exposed to serious risks which outweigh the benefits of these medicines. In order to protect public health, the CMDh endorsed the PRAC recommendation to withdraw the marketing authorisations of flupirtine-containing medicines.


1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.

Key facts

About this medicine
Approved name
Flupirtine-containing medicinal products
International non-proprietary name (INN) or common name
flupirtine
Class
Analgesics
About this procedure
Current status
Position provided by CMDh
Reference number
EMEA/H/A-31/1458
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-CMDh
Authorisation model
Nationally authorised product(s)
Key dates and outcomes
Procedure start date
26/10/2017
PRAC recommendation date
08/02/2018
CHMP opinion/CMDh position date
21/03/2018
Outcome
Revocation

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Position provided by CMDh

  • List item

    Flupirtine Article-31 referral - Withdrawal of pain medicine flupirtine endorsed (PDF/99.09 KB)


    First published: 23/03/2018
    Last updated: 23/03/2018

  • List item

    Flupirtine Article-31 referral - Annex II (PDF/51.79 KB)


    First published: 04/05/2018
    Last updated: 04/05/2018

  • List item

    Flupirtine Article-31 referral - Annex I (PDF/53.96 KB)


    First published: 04/05/2018
    Last updated: 04/05/2018

  • List item

    Flupirtine Article-31 referral - Annex III (PDF/25.51 KB)


    First published: 04/05/2018
    Last updated: 04/05/2018

  • List item

    Flupirtine Article-31 referral - Withdrawal of pain medicine flupirtine endorsed (PDF/99.09 KB)


    First published: 23/03/2018
    Last updated: 23/03/2018

  • 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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