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During its September meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) affirmed that atrial fibrillation will now be listed as a common side effect in the Summary of Product Characteristics for medicinal products containing omega-3-acid ethyl esters. If atrial fibrillation occurs, administration of the medication must be permanently discontinued.
Omega-3-acid ethyl esters are employed in the treatment of hypertriglyceridemia when lifestyle modifications, especially those concerning diet, have not adequately reduced blood triglyceride levels. Hypertriglyceridemia is a risk factor for coronary heart disease.
In the course of a Periodic Safety Update Single Assessment Procedure, the EMA’s safety committee scrutinized comprehensive overviews and meta-analyses of controlled clinical trials. Experts identified a dose-dependent escalation in the risk of atrial fibrillation in patients with cardiovascular diseases or cardiovascular risk factors who were undergoing treatment with omega-3-acid ethyl esters, as opposed to those receiving a placebo. This risk was most pronounced at a dosage of 4 grams per day.
The PRAC will propose an amendment to the Summary of Product Characteristics for formulations containing omega-3-acid ethyl esters. The objective is to apprise physicians, pharmacists, and patients of the potential for atrial fibrillation. Healthcare professionals will soon receive a notification (direct healthcare professional communication) containing further information.
