The EMA reviewed all the available evidence and concluded that the small relative-risk reduction seen in the original 1999 open-label study of omega-3 supplements in secondary prevention, which supported the initial authorisation of these medicines, was not confirmed in more recent randomised controlled trials.
This indication is therefore being removed from the prescribing information for the two omega 3-fatty acid medicines currently available, Teromeg and Omacor. Both are 1g capsules containing ethyl esters of the fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
Earlier this year a randomised, placebo-controlled trial in 25,000 people failed to show any protective effect of omega-3 supplements against cardiovascular disease or cancer.
Omega-3 fatty acids can still be prescribed for the treatment of hypertriglyceridaemia when dietary measures alone are insufficient.