The European Medicines Agency's safety committee (PRAC) confirmed in its September meeting that atrial fibrillation will be added as a common side effect in the Summary of Product Characteristics for medicinal products containing omega-3-acid ethyl esters.

Omega-3-acid ethyl esters are used to treat hypertriglyceridemia, a condition where lifestyle changes have not sufficiently lowered blood triglyceride levels, which is a risk factor for coronary heart disease.

The PRAC's analysis of systematic overviews and meta-analyses of clinical studies revealed a dose-dependent increase in the risk of atrial fibrillation in patients with cardiovascular diseases or risk factors who were treated with omega-3-acid ethyl esters, with the highest risk observed at a dose of 4 g/d.

As a response to these findings, the PRAC will recommend an update to the Summary of Product Characteristics for products containing omega-3-acid ethyl esters to inform healthcare professionals and patients about the risk of atrial fibrillation.

A notification, in the form of direct healthcare professional communication, will be sent to healthcare professionals soon to provide them with further details regarding this update.