EMA concludes that omega-3 fatty acids not effective for secondary prevention

Following a review of all the available data, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has concluded that omega-3 fatty acid medications are not effective for the secondary prevention of cardiovascular disease following myocardial infarction (MI).

Omega-3 fatty acid medicines contain the fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), commonly found in fish oils. They have been authorised for use in combination with other medicines for the secondary prevention of cardiovascular disease post-MI in several EU countries since 2000 (including the UK, although they are not recommended by NICE for this purpose). At the time of authorisation, there was some evidence to suggest that they are associated with modest cardiovascular benefits, including the results of the 1999 open-label GISSI Prevenzione study, which showed that 1g daily omega-3 fatty acid supplementation post-MI was associated with a small decrease in the relative risk of death, MI and stroke.

However, the results of the CHMP’s latest review, which garnered evidence from several retrospective cohort studies, randomised controlled trials and meta-analyses, have not confirmed the beneficial effects of omega-3 fatty acids and therefore they will no longer be authorised for the secondary prevention of MI in the EU.

Nevertheless, the CHMP review found no new safety concerns with omega-3 fatty acid medicines. Furthermore, the findings do not affect their use in the treatment of hypertriglyceridaemia, and they will continue to be authorised for this indication.

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