European Medicines Agency will no longer authorize use of omega-3s for heart attack patients, based on review of available research

December 17, 2018

The European Medicines Agency (EMA) will no longer authorize omega-3 fatty acids for secondary prevention of myocardial infarction, based on an eight-month review of research.

The European Medicines Agency (EMA) will no longer authorize omega-3 fatty acids for secondary prevention of myocardial infarction, based on an eight-month review by EMA of “accumulated” data. Since 2000, omega-3s were authorized by EMA for use after heart attacks in combination with other medicines at a dose of 1 g per day. While the agency says it has no safety concerns, EMA has concluded that “the balance between the benefits and risks of these medicines to prevent recurrence of heart disease or stroke is now negative.”

EMA has yet to release details from its full review, but said on its website that it looked at “results of the open-label ‘GISSI Prevenzione’ study performed in 1999 which supported the initial authorisation of these medicines, as well as retrospective cohort studies, more recent randomised controlled trials, and results of meta-analyses.” While earlier studies saw a modest risk reduction, said the agency, subsequent research could not confirm these benefits. While EMA will no longer authorize the use omega-3s in individuals who are recovering from heart attacks, this decision does not affect its authorization for using omega-3s in the treatment of hypertriglyceridaemia.