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

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

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
About this procedure
Current status
CMDh final position
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.

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

  • 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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