EMA ( European Medicines Agency ) has concluded that Omega-3 fatty acid medicines are not effective in preventing further heart and blood vessels problems in patients who have had a myocardial infarction.
The conclusion, based on a review of data accumulated over the years, means that these medicines will no longer be authorised for such use.
Omega-3 fatty acid medicines have been authorised for use after a myocardial infarction, in combination with other medicines, in several EU ( European Union ) countries since 2000, at a dose of 1 g per day.
At the time of their authorisation, available data showed some benefits in reducing serious problems with the heart and blood vessels, although the benefits were considered modest.
Further data that have become available since then have not confirmed the beneficial effects of these medicines for this use.
Although there are no new safety concerns, EMA’s human medicines committee ( CHMP ) concluded that the balance between the benefits and risks of these medicines to prevent recurrence of heart disease or stroke is now negative.
These medicines can still be used to reduce levels of certain types of blood fat called triglycerides.
Information for healthcare professionals
Omega-3 fatty acid medicines will no longer be authorised for secondary prevention after myocardial infarction.
This is based on a review of all the available data on the efficacy of Omega-3 fatty acid medicines in this indication. The review 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.
The review concluded that, while a small relative risk reduction was seen in the original open label GISSI Prevenzione study, such beneficial effects were not confirmed in more recent randomised controlled trials.
This review does not affect the authorisation of Omega-3 fatty acid medicines for the treatment of hypertriglyceridaemia.
Omega 3-fatty acid medicines contain the fatty acids eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) commonly found in fish oils.
They are taken by mouth. ( Xagena )
Source: EMA, 2018