Hydroxyzine

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

Overview

New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines

Use to be avoided in patients at greatest risk and doses to be kept low

The CMDh1 has agreed by consensus new measures to minimise the risk of effects on heart rhythm with medicines containing the antihistamine hydroxyzine. The measures include restricting use of hydroxyzine in patients at high risk of heart rhythm problems and using the medicine at the lowest effective dose for as short a time as possible.

Hydroxyzine medicines are available in most EU countries. Their approved uses (indications) vary between countries and may include use to treat anxiety disorders, for relief of pruritus (itching), as premedication before surgery, and treatment of sleep disorders.

Recommendations for these new measures were originally made by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed a previously known risk of QT interval prolongation and torsades de pointes, alterations in the electrical activity of the heart that can lead to abnormal heart rhythms and cardiac arrest (stopping of the heart). Having assessed the available evidence, including published studies and data from regular safety monitoring, the PRAC concluded that the risk did not differ between indications and that such events are most likely to occur in patients who have risk factors. The PRAC therefore recommended that the risk be managed by restricting hydroxyzine use in those most at risk of heart rhythm problems and reducing exposure to the medicine.

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. In particular, the product information of hydroxyzine-containing medicines will be updated with new dosing recommendations and warnings on use in patients who have risk factors for heart rhythm disturbances or who are taking certain other medicines.


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
Hydroxyzine
International non-proprietary name (INN) or common name
hydroxyzine
Associated names
Atarax
About this procedure
Current status
CMDh final position
Reference number
EMEA/H/A-31/1400
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
08/05/2014
PRAC recommendation date
12/02/2015
CHMP opinion/CMDh position date
25/03/2015
Outcome
Risk minimisation measures

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Position provided by CMDh

  • List item

    Hydroxyzine Article-31 referral - New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines (PDF/82.89 KB)

    Adopted

    First published: 27/03/2015
    Last updated: 27/03/2015
    EMA/149624/2015

  • List item

    Hydroxyzine Article-31 referral - Annex II (PDF/45.39 KB)


    First published: 08/06/2015
    Last updated: 08/06/2015

  • List item

    Hydroxyzine Article-31 referral - Annex IV (PDF/37.01 KB)


    First published: 08/06/2015
    Last updated: 08/06/2015

  • List item

    Hydroxyzine Article-31 referral - PRAC assessment report (PDF/223.75 KB)


    First published: 20/04/2015
    Last updated: 20/04/2015
    EMA/154392/2015

  • List item

    Hydroxyzine Article-31 referral - Annex III (PDF/57.63 KB)


    First published: 27/03/2015
    Last updated: 08/06/2015

  • List item

    Hydroxyzine Article-31 referral - New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines (PDF/82.89 KB)

    Adopted

    First published: 27/03/2015
    Last updated: 27/03/2015
    EMA/149624/2015

  • List item

    Hydroxyzine Article-31 referral - Annex I (PDF/185.8 KB)


    First published: 08/05/2014
    Last updated: 08/06/2015

  • 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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