Omega-3 fatty acids do not provide secondary prevention after heart attack: EMA

Stop using omega-3 fatty acids for secondary prevention after a heart attack, advises the European Medicines Agency (EMA).

The European Medicines Agency (EMA) has concluded that while a small relative risk reduction was seen in the original GISSI Prevenzione study, the beneficial effects were not confirmed in more recent randomized controlled trials. Therefore the agency is advising that omega-3 medicines should no longer be authorized for this indication.

Omega-3 fatty acids are a class of essential polyunsaturated fatty acids with the double bond in the third carbon position from the methyl terminal (hence the use of "3" in their description). Foods high in omega-3 fatty acids include salmon, halibut, sardines, albacore, trout, herring, walnut, flaxseed oil, and canola oil. Other foods that contain omega-3 fatty acids include shrimp, clams, light chunk tuna, catfish, cod, and spinach.

Medicines of omega-3 fatty acid that contain a combination of eicosapentaenoic acid and docosahexaenoic acid at a dose of 1 g/day are not effective for preventing further problems with the heart and blood vessels in patients who have had a heart attack. This implies that omega-3 medicines will no longer be authorized to be used in this way. But they can still be used for reduction in the levels of certain types of blood fat called triglycerides.

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

The decision follows a re-examination of the evidence that was requested by some of the product license holders after the EMA first made the recommendation in December 2018.

EMA’s committee for human medicines, CHMP, has 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 authorizations of these medicines should be updated to remove this use.

The EMA decision will now be forwarded to the European Commission for a final legally binding decision applicable to all EU Member States.