Hydroxyzine

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

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Recommendations for these new measures were originally made by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed a previously known risk of QT interval prolongation and torsades de pointes,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
Position provided by CMDh
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

  • 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

    How useful was this page?

    Add your rating