Codeine-containing medicinal products for the treatment of cough or cold in paediatric patients

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

Overview

Codeine not to be used in children below 12 years for cough and cold

The CMDh1 has agreed by consensus new measures to minimise the risk of serious side effects, including breathing problems, with codeine-containing medicines when used for cough and cold in children. As a result of these new measures:

  • Use of codeine for cough and cold is now contraindicated in children below 12 years. This means it must not be used in this patient group.
  • Use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years who have breathing problems.

The effects of codeine are due to its conversion into morphine in the body. Some people convert codeine to morphine at a faster rate than normal, resulting in high levels of morphine in their blood. High levels of morphine can lead to serious effects, such as breathing difficulties.

The new measures follow a review by EMA's Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC considered that, although morphine-induced side effects may occur in patients of all ages, the way codeine is converted into morphine in children below 12 years is more variable and unpredictable, making this population at special risk of such side effects. In addition, children who already have problems with their breathing may be more susceptible to respiratory problems due to codeine. The PRAC also noted that cough and cold are generally self-limiting conditions and the evidence that codeine is effective at treating cough in children is limited.

In addition to the new measures for children, codeine must also not be used in people of any age who are known to convert codeine into morphine at a faster rate than normal ('ultra-rapid metabolisers') nor in breastfeeding mothers, as codeine can harm the baby because it passes into breast milk.

This review comes after a previous review of codeine for pain relief in children, which resulted in several restrictions being introduced in order to ensure that the medicine was used as safely as possible. As it was realised that similar considerations could apply to the use of codeine for cough and cold in children, a second EU-wide review of such use was started. The restrictions for codeine for cough and cold are largely in line with the previous recommendations for codeine when used for pain relief.

As the CMDh has now agreed the PRAC measures by consensus, the measures will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.


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
Codeine-containing medicinal products for the treatment of cough or cold in paediatric patients
International non-proprietary name (INN) or common name
codeine
About this procedure
Current status
Position provided by CMDh
Reference number
EMEA/H/A-31/1394
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
10/04/2014
PRAC recommendation date
12/03/2015
CHMP opinion/CMDh position date
22/04/2015
Outcome
Variation

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Position provided by CMDh

  • List item

    Codeine Article-31 referral - Codeine not to be used in children below 12 years for cough and cold (PDF/77.98 KB)

    Adopted

    First published: 24/04/2015
    Last updated: 24/04/2015

  • List item

    Codeine Article-31 referral - Annex II (PDF/65.4 KB)


    First published: 18/05/2015
    Last updated: 18/05/2015

  • List item

    Codeine Article-31 referral - Annex IV (PDF/21.83 KB)


    First published: 18/05/2015
    Last updated: 18/05/2015

  • List item

    Codeine Article-31 referral - Codeine not to be used in children below 12 years for cough and cold (PDF/77.98 KB)

    Adopted

    First published: 24/04/2015
    Last updated: 24/04/2015

  • List item

    Codeine Article-31 referral - Annex III (PDF/77 KB)


    First published: 24/04/2015
    Last updated: 18/05/2015

  • List item

    Codeine Article-31 referral - Annex I (PDF/394.86 KB)


    First published: 11/04/2014
    Last updated: 18/05/2015
    EMA/713187/2012

  • 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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