Omega-3 fatty acid medicines will no longer be authorised for the secondary prevention of cardiovascular disease (CVD) following myocardial infarction. The decision is the result of a review by the European Medicines Agency (EMA) which concluded that the products are not effective in preventing further cardiac and vascular problems.
Omega-3 fatty acid medicines have been authorised for the secondary prevention of CVD in several EU countries since 2000, at a dose of 1 g per day. At the time of their authorisation, available data showed some benefits, although the gains were considered modest. Further data that have become available since then have not confirmed the beneficial effects.
The review looked at results from 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 meta-analyses.
The review concluded that, while a small relative risk reduction was seen in the original open-label GISSI Prevenzione study, these beneficial effects were not confirmed in more recent randomised controlled trials.
Although there are no new safety concerns, the EMA concluded that the benefit-risk balance of these medicines to prevent recurrence of heart disease or stroke is now negative.