Omega-3 fatty acid medicines

Current status:
Opinion provided by Committee for Medicinal Products for Human Use


Update of 1 February 2019:

Following the CHMP’s recommendation of 13 December 2018, some of the marketing authorisation holders involved with this review have requested a re-examination. Upon receipt of the grounds for their requests, the CHMP will start a re-examination, which is expected to conclude at the CHMP meeting of 25-29 March 2019.

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

EMA has concluded that omega-3 fatty acid medicines are not effective in preventing further heart and blood vessels problems in patients who have had a heart attack. The conclusion, based on a review of data accumulated over the years, means that these medicines will no longer be authorised for such use.

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, although the benefits were considered modest. Further data that have become available since then have not confirmed the beneficial effects of these medicines for this use.

Although there are no new safety concerns, EMA’s human medicines committee (CHMP) concluded that the balance between the benefits and risks of these medicines to prevent recurrence of heart disease or stroke is now negative.

These medicines can still be used to reduce levels of certain types of blood fat called triglycerides.

Key facts

Approved name
Omega-3 fatty acid medicines
International non-proprietary name (INN) or common name

Omega-3 fatty acid medicines

Reference number
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.

Opinion provided by Committee for Medicinal Products for Human Use
Opinion date

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:


How useful was this page?

Add your rating
1 rating
5 ratings