The European Medicine Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has concluded that omega-3 fatty acid medicines are not effective for secondary prevention after myocardial infarction (MI).
Omega-3 fatty acid medicines at a dose of 1 g per day have been authorized in several European Union countries since 2000 for preventing heart disease or stroke after MI and for lowering high triglycerides.
When they were authorized, the available data showed « some benefits in reducing serious problems with the heart and blood vessels, although the benefits were considered modest, » the EMA said in a news release. « Further data that have become available since then have not confirmed the beneficial effects of these medicines for this use. »
The CHMP’s conclusion, released at their December meeting, means that these medicines will no longer be authorized for such use.
Their review included results of the open-label GISSI Prevenzione study from 1999, which supported the initial authorization of these products, as well as retrospective cohort studies, more recent randomized controlled trials, and results of meta-analyses…