Does parenteral Omega-3 fatty acid administration increase the risk of atrial fibrillation? An analysis of the current evidence
Abstract
Background & aims: In 2023, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) issued new safety information on oral fish oil (FO) pharmacotherapy. This information indicated a dose-related increased risk of atrial fibrillation (AF) with FO in patients with established cardiovascular disease (CVD). The aim of this study is to analyse the existing evidence on this risk and establish whether it can be extrapolated to FO-enriched intravenous lipid emulsions (FO-ILEs) or to other patient groups, such as critically ill patients with organ dysfunction.
Methods: We searched for large (>50,000 participants) systematic reviews analysing the effect of long-term (>1 year) oral FO pharmacotherapy on the incidence of AF in non-critically ill patients with CVD. Reviews also had to include at least one large randomised study (>1,000 participants) on this topic. We examined these reviews with regard to specific limitations. We also estimated on a theoretical basis the extent to which short-term use of FO-ILEs in critically ill patients might alter plasmatic EPA (eicosapentaenoic acid)/DHA (docosahexaenoic acid) concentrations or myocardial EPA/DHA content, and investigated how these changes might affect the cardiac conduction system. We identified six meta-analyses, which consistently showed an increased risk of AF (primary, secondary, exploratory or safety outcome). In these analyses, however, significant bias may arise from including studies that…
How strong is the evidence?
Evidence Hub reads this as a systematic review, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 50,000 participants or records.
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