Flupirtine-containing medicinal products

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CMDh final position
Current status
CMDh final position

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
CMDh final position
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.

Authorisation model
Nationally authorised product(s)
Decision making model
PRAC-CMDh
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

  • 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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