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.
14 December 2018
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.
Information for patients
• Latest data on omega-3 fatty acid medicines show that these medicines are not effective at
preventing further problems with the heart and blood vessels in patients who have had a heart
attack.
• There are alternative treatment options to prevent recurrence of heart problems after 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
