EMA Warns That Omega-3-Acid Ethyl Esters May Cause Atrial Fibrillation

I am not recommending this and/or condemning this. According to this study, the warning level of a daily dose was 4Gm ( 4000mg) That would entail taking > 3 capsules daily of the typical strength for 1200 mg of omega-3 per capsule.  This study does not state that those pts taking < 4 Gm of omega-3 is safe of developing A-FIB.

https://www.medscape.com/viewarticle/997348

In its September meeting, the safety committee (Pharmacovigilance Risk Assessment Committee [PRAC]) of the European Medicines Agency (EMA) confirmed that atrial fibrillation will now be included as a common side effect in the Summary of Product Characteristics for medicinal products containing omega-3-acid ethyl esters.

Should atrial fibrillation develop, intake of the medication must be stopped permanently.

Omega-3-acid ethyl esters are used to treat hypertriglyceridemia if lifestyle changes, particularly those related to nutrition, have not been sufficient to lower the blood triglyceride level. Hypertriglyceridemia is a risk factor for coronary heart disease.

During a Periodic Safety Update Single Assessment Procedure, the EMA safety committee analyzed systematic overviews and meta-analyses of randomized, controlled clinical studies. Experts found a dose-dependent increase in the risk for atrial fibrillation in patients with cardiovascular diseases or cardiovascular risk factors who were being treated with omega-3-acid ethyl esters compared with those treated with placebo.

The observed risk was at its highest at a dose of 4 g/d.

The PRAC will recommend an update to the Summary of Product Characteristics for preparations that contain omega-3-acid ethyl esters. The aim is to inform physicians, pharmacists, and patients of the risk for atrial fibrillation. A notification (direct healthcare professional communication) will be sent to healthcare professionals soon to inform them of further details.

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