Metamizole containing medicinal products

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

Overview

EMA recommends aligning doses of metamizole medicines and their use during pregnancy and breastfeeding

On 13 December 2018, following a review of medicines containing the painkiller metamizole, EMA recommended that the maximum daily dose of the medicine and the contraindications to its use in pregnancy or women who are breastfeeding should be harmonised for all products on the EU market. The recommendation addressed inconsistencies in the product information for metamizole medicines, which are marketed in many EU member states to treat severe pain and fever that cannot be controlled with other treatments.

The review was carried out by EMA’s human medicines committee (CHMP) at the request of Poland, which was concerned by the substantial differences in the recommendations on the use of metamizole in different EU countries, given that it is known the medicine may occasionally cause severe side effects, such as effects on the blood.

The Agency reviewed the available information on the way the medicine is distributed in the body, how it works and the limited data on its effects on the unborn child or breast-fed infant.

EMA’s recommendations include setting a maximum single dose by mouth of 1,000 mg, taken up to 4 times daily (a maximum daily dose of 4,000 mg), in patients from 15 years of age. Treatment should start at the lowest recommended dose and only be increased if needed. If given by injection the total daily dose should not exceed 5,000 mg. Doses in younger patients should be based on their body weight but some products may be unsuitable because of their strength.

Although metamizole has been on the market for nearly a century, evidence of its effects in pregnancy and breastfeeding is scarce. The review found little to suggest problems in early pregnancy, and single doses in the first 6 months might be acceptable if other analgesics cannot be used. However, there was some evidence of effects on the kidneys and circulation of the fetus if the medicine were used in the last 3 months of pregnancy, and the medicine should therefore not be used in this period. As a precaution, metamizole should not be used during breastfeeding because the infant may receive high amounts of the medicine in the milk relative to the infant’s weight.

EMA’s recommendations were forwarded to the European Commission, which issued a final legally binding decision valid across the EU on 20 March 2019.

Key facts

About this medicine
Approved name
Metamizole containing medicinal products
International non-proprietary name (INN) or common name
metamizole
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1469
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)
Key dates and outcomes
CHMP opinion date
13/12/2018
EC decision date
20/03/2019

All documents

Procedure started

European Commission final decision

  • List item

    Metamizole Article-31 referral - EMA recommends aligning doses of metamizole medicines and their use during pregnancy and breastfeeding (PDF/86.33 KB)


    First published: 14/12/2018
    Last updated: 15/04/2019
    EMA/191666/2019

  • List item

    Metamizole Article-31 referral - Annex II (PDF/42 KB)


    First published: 28/03/2019

  • List item

    Metamizole Article-31 referral - CHMP assessment report (PDF/279.62 KB)

    Adopted

    First published: 28/03/2019
    EMA/143912/2019

  • List item

    Metamizole Article-31 referral - Annex III (PDF/359.35 KB)


    First published: 14/12/2018
    Last updated: 28/03/2019

  • List item

    Metamizole Article-31 referral - Annex I (PDF/358.31 KB)


    First published: 01/06/2018
    Last updated: 28/03/2019

  • 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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