The European Medicines Agency (EMA) has confirmed that omega-3 fatty acid medicines containing a combination of ethyl ester of eicosapentaenoic acid and docosahexaenoic acid at a dose of 1 g/day will no longer be authorised for secondary prevention of cardiovascular events after myocardial infarction (MI).
The decision follows a re-examination of the evidence that was requested by some of the product licence holders after the EMA first made the recommendation in December 2018.
The latest review examined the results of the open-label GISSI Prevenzione study performed in 1999, which supported the initial authorisation of these medicines. Additionally, the review considered more recent randomised controlled clinical trials, retrospective cohort studies and meta-analyses.
The EMA 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 randomised controlled trials. The agency is advising that omega-3 medicines should no longer be authorised for this indication.
The decision is not based on any new safety concerns, and omega-3 products will continue to be authorised for the treatment of hypertriglyceridaemia.
The EMA decision will now be forwarded to the European Commission for a final legally binding decision applicable to all EU Member States.