Metamizole containing medicinal products

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

Approved name
Metamizole containing medicinal products
International non-proprietary name (INN) or common name

metamizole

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.

Status
European Commission final decision
Opinion date
13/12/2018
EC decision date
20/03/2019

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

News

How useful was this page?

Add your rating
Average
1 rating
2 ratings
1 rating
2 ratings