Omega-3-acid ethyl ester medicines
Dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or risk factors.
Published: 25 January 2024
Systematic reviews and meta-analyses of randomised controlled trials have highlighted a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors treated with omega-3-acid ethyl ester medicines compared to placebo.
As a result, atrial fibrillation is now listed as an adverse drug reaction with a “common” frequency for medicines containing omega-3-acid ethyl esters licensed for the treatment of hypertriglyceridemia.
Further details and advice for healthcare professionals can be found on the MHRA website.