Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision

Table of contents

Current status
European Commission final decision

Overview

EMA confirms omega-3 fatty acid medicines are not effective in preventing further heart problems after a heart attack

EMA has confirmed that omega-3 fatty acid medicines containing a combination of an ethyl ester of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) at a dose of 1 g per day are not effective in preventing further problems with the heart and blood vessels in patients who have had a heart attack. This is the outcome of a re-examination requested by some of the companies that market the medicines concerned, following EMA’s original recommendation in December 2018.

This means that these medicines should no longer be used in this way. However, they can still be used to reduce levels of certain types of blood fat called triglycerides.

Omega-3 fatty acid medicines have been authorised for use after a heart attack, in combination with other medicines, in several EU countries since 2000, at a dose of 1 g per day. At the time of their authorisation, available data showed some benefits in reducing serious problems with the heart and blood vessels.

EMA’s committee for human medicines, CHMP, re-assessed the evidence accumulated over the years on these medicines for this specific use and consulted additional experts in the field. It concluded that, although there are no new safety concerns, the effectiveness of these medicines in preventing recurrence of problems with the heart and blood vessels has not been confirmed.

EMA concluded that the marketing authorisations of these medicines should be updated to remove this use.

Key facts

About this medicine
Approved name
Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction
International non-proprietary name (INN) or common name
Omega-3 fatty acid ethyl esters
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1464
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)
Key dates and outcomes
CHMP opinion date
13/12/2018
EC decision date
06/06/2019

All documents

Procedure started

Opinion provided by Committee for Medicinal Products for Human Use

  • List item

    Omega-3 acid ethyl esters - Annex II (PDF/184.17 KB)


    First published: 13/06/2019

  • List item

    Omega-3 acid ethyl esters - Annex III (PDF/27.78 KB)


    First published: 14/12/2018
    Last updated: 13/06/2019

  • List item

    Omega-3 acid ethyl esters - Annex I (PDF/208.87 KB)


    First published: 26/03/2018
    Last updated: 13/06/2019

    • European Commission final decision

  • List item

    Omega-3 acid ethyl esters - EMA confirms omega-3 fatty acid medicines are not effective in preventing further heart problems after a heart attack (PDF/84.61 KB)


    First published: 01/02/2019
    Last updated: 13/06/2019
    EMA/328211/2019

  • List item

    Omega-3 acid ethyl esters - Assessment report following the re-examination procedure (PDF/1009.84 KB)

    Adopted

    First published: 13/06/2019
    EMA/303982/2019

    • 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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