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

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 Omega-3 fatty acid medicines - Omega-3 fatty acid medicines no longer considered effective in preventing heart disease 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.

Information for patients

• A review of all available data on omega-3 fatty acid medicines containing a combination of an ethyl ester of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) shows that these medicines are not effective at preventing further problems with the heart and blood vessels in patients who have had a heart attack.
• If you are using omega-3 fatty acid medicines to reduce the risk of heart problems your doctor will advise on the best alternative treatment option for you.
• Omega-3 fatty acid medicines are still authorised for reducing levels of certain types of blood fat called triglycerides. Therefore, if you are using these medicines for this purpose you should continue your treatment.
• There are no new safety concerns associated with the use of omega-3 medicines.
• If you have any question or concern about omega-3 fatty acid medicines contact your treating doctor.

Information for healthcare professionals

• Omega-3 fatty acid medicines containing a combination of an ethyl ester of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) will no longer be authorised for secondary prevention after myocardial infarction.
• This is based on a review of all the available data on the efficacy of omega-3 fatty acid medicines in this indication.
• The review looked at results of the open-label ‘GISSI Prevenzione’ study performed in 1999 which supported the initial authorisation of these medicines, as well as more recent randomised controlled clinical trials, retrospective cohort studies and meta-analyses.
• The review concluded that, while a small relative risk reduction was seen in the original open label GISSI Prevenzione study, the beneficial effects were not confirmed in more recent randomised controlled trials.

This review does not affect the authorisation of omega-3 fatty acid medicines for the treatment of hypertriglyceridaemia.

More about the medicine

• The review concerned omega-3 fatty acid medicines containing a combination of an ethyl ester of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). EPA and DHA are commonly found in fish oils.

• Omega-3 fatty acid medicines are taken by mouth and have been authorised in several EU countries through national procedures. This review focused on the medicines' use in patients who have had a heart attack.

More about the procedure

The review of omega-3 fatty acid medicines was started on 22 March 2018 at the request of the Swedish medicines agency under Article 31 of Directive 2001/83/EC.

The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted an opinion in December 2018.

Following a request from some marketing authorisation holders, the CHMP re-examined its original opinion and adopted its final opinion, which was forwarded to the European Commission. The European Commission issued a final legally binding decision applicable in all EU Member States on 6 June 2019.

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

Reference Number: EMA/328211/2019 Summary:

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

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

Omega-3 acid ethyl esters - Start of referral

Reference Number: EMA/177123/2018

Omega-3 acid ethyl esters - Notification

Reference Number: EMEA/H/A-31/1464

Omega-3 acid ethyl esters - List of questions

Reference Number: EMEA/H/A-31/1464

Omega-3 acid ethyl esters - Timetable for the procedure

Reference Number: EMA/CHMP/171344/2018 Rev.4

Opinion provided by Committee for Medicinal Products for human Use

Omega-3 acid ethyl esters - Annex II

Omega-3 acid ethyl esters - Annex III

Omega-3 acid ethyl esters - Annex I

European Commission final decision

Omega-3 acid ethyl esters - Assessment report following the re-examination procedure

Adopted Reference Number: EMA/303982/2019

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

Reference Number: EMA/328211/2019 Summary:

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

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.