Domperidone-containing medicines

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

Overview

 

On 23 April 2014, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) endorsed recommendations to restrict the use of domperidone-containing medicines. The CMDh, a medicines regulatory body representing the EU Member States, agreed that these medicines should only be used to relieve symptoms of nausea and vomiting, that doses and length of treatment should be restricted and that they should be adjusted carefully by the patient's weight where available for use in children. The recommendations were originally made by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) at its meeting of 3-6 March, after a careful evaluation of the available evidence on the benefits and risks of such medicines.

Domperidone-containing medicines have been authorised nationally in individual Member States of the EU for the treatment of nausea and vomiting of various causes but also for the management of symptoms such as bloating, discomfort and heartburn.

The review of domperidone was carried out at the request of the Belgian medicines authority over concerns about the medicine's effects on the heart. The injectable form of domperidone was withdrawn in 1985 because of such side effects. Serious effects on the heart with domperidone, including prolongation of the QT interval (an alteration of the electrical activity of the heart) and arrhythmias (unstable heartbeats), have previously been evaluated by the EMA and the product information updated with relevant warnings. However, cases of heart problems in patients using the medicine continued to be reported, and the PRAC was therefore asked to examine whether the benefits still outweighed the risks for these medicines in their approved uses and forms, and whether their marketing authorisations should be maintained or changed across the EU.

The CMDh confirmed by majority the PRAC recommendation that domperidone-containing medicines should remain available and may continue to be used in the EU for the management of the symptoms of nausea and vomiting, but that the recommended dose should be reduced to 10 mg up to three times daily by mouth for adults and adolescents weighing 35 kg or more. These patients may also be given the medicine as suppositories of 30 mg twice daily. Products licensed in children and adolescents weighing less than 35 kg should be given by mouth at a dose of 0.25 mg per kg bodyweight up to three times daily. Measuring devices will be included with liquid formulations to allow accurate dosing by bodyweight. The medicine should not normally be used for longer than one week.

Domperidone will no longer be authorised to treat other conditions such as bloating or heartburn. It must not be given to patients with moderate or severe impairment of liver function, or in those who have existing abnormalities of electrical activity in the heart or heart rhythm, or who are at increased risk of such effects. In addition, it should not be used with other medicines that have similar effects on the heart or reduce the breakdown of domperidone in the body (thus increasing the risk of side effects). The product information has been amended appropriately. Products supplying a dose of 20 mg by mouth, and suppositories of 10 or 60 mg are no longer recommended for use and should be withdrawn, as should combination products with cinnarizine (an antihistamine) where available.

Although the scope of the review did not cover use outside the licensed indications (off-label use) the principles behind these recommendations should be considered whenever domperidone is used.

As the CMDh position was adopted by majority vote, it was sent to the European Commission, which endorsed it and issued a final legally binding decision valid throughout the EU.

Key facts

About this medicine
Approved name
Domperidone-containing medicines
International non-proprietary name (INN) or common name
domperidone
Class
-
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1365
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
07/03/2013
PRAC recommendation date
06/06/2014
CHMP opinion/CMDh position date
24/04/2014
EC decision date
01/09/2014
Outcome
Variation

All documents

Procedure started

  • List item

    Domperidone Article-31 referral - Annex I (PDF/556.78 KB)


    First published: 08/03/2013
    Last updated: 11/09/2014
    EMA/147415/2013 Rev.2

  • List item

    Domperidone Article-31 referral - Timetable for the procedure (PDF/79.34 KB)


    First published: 08/03/2013
    Last updated: 10/12/2013
    EMA/PRAC/127280/2013 Rev.2

  • List item

    Domperidone Article-31 referral - Review started (PDF/64.8 KB)


    First published: 08/03/2013
    Last updated: 08/03/2013
    EMA/140423/2013

  • List item

    Domperidone Article-31 referral - Notification (PDF/468.58 KB)


    First published: 08/03/2013
    Last updated: 08/03/2013

  • List item

    Domperidone Article-31 referral - PRAC list of questions (PDF/69.8 KB)


    First published: 08/03/2013
    Last updated: 08/03/2013
    EMA/PRAC/124198/2013

  • Recommendation provided by Pharmacovigilance Risk Assessment Committee

    Position provided by CMDh

  • List item

    Domperidone Article-31 referral - CMDh divergent position (PDF/34.82 KB)


    First published: 11/09/2014
    Last updated: 11/09/2014

  • List item

    CMDh confirms recommendations on restricting use of domperidone-containing medicines (PDF/88.83 KB)


    First published: 25/04/2014
    Last updated: 25/04/2014
    EMA/236452/2014

  • List item

    Domperidone Article-31 referral - Annex III (PDF/165.66 KB)


    First published: 25/04/2014
    Last updated: 11/09/2014

  • European Commission final decision

  • List item

    Domperidone Article-31 referral - Restrictions on the use of domperidone-containing medicines (PDF/102.35 KB)


    First published: 11/09/2014
    Last updated: 11/09/2014
    EMA/465179/2014

  • List item

    Domperidone Article-31 referral - Restrictions on the use of domperidone-containing medicines (PDF/102.35 KB)


    First published: 11/09/2014
    Last updated: 11/09/2014
    EMA/465179/2014

  • List item

    Domperidone Article-31 referral - Annex II (PDF/94.21 KB)


    First published: 11/09/2014
    Last updated: 11/09/2014

  • List item

    Domperidone Article-31 referral - Annex IV (PDF/26.46 KB)


    First published: 11/09/2014
    Last updated: 11/09/2014

  • 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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