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Pharmacovigilance data indicate a strong link between DOACs and atrial fibrillation, most pronounced for edoxaban.
A large pharmacovigilance analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS) has identified a strong connection between direct oral anticoagulants (DOACs) and atrial fibrillation (AF), highlighting a potential safety signal that may influence clinical monitoring and decision-making.
DOACs—including apixaban, rivaroxaban, dabigatran, and edoxaban—are widely prescribed for the prevention and treatment of thromboembolic disorders such as stroke and venous thromboembolism. Although they yield advantages over warfarin, including fewer interactions and predictable pharmacokinetics, real-world safety data continue to reveal emerging adverse event patterns. Hence, this retrospective disproportionality study sought to fill this gap.
Researchers analyzed FAERS data from Q1 2014 to March 2025, focusing on reports where a DOAC was the primary suspected drug, and AF was classified as a serious adverse event. A total of 5,262 AF cases were identified, with a near-equal distribution between males (51%) and females (49%), and the highest occurrence in patients aged 65–85 years.
The study illustrated a strong class-wide signal for AF associated with DOAC use, with a reporting odds ratio (ROR) of 7.05, proportional reporting ratio of 6.84, chi-square value of 22,677, and information component of 2.59. Among individual agents, edoxaban portrayed the highest association (ROR 13.03), followed by apixaban (9.23), dabigatran (8.52), dabigatran etexilate mesylate (4.59), and rivaroxaban (3.88), indicating variability in signal strength across drugs.
Despite these findings, the analysis does not establish a causal link between DOACs and AF. The observed association may be influenced by confounding factors, as patients receiving DOACs are typically older and have comorbid conditions such as hypertension, diabetes, and heart failure, which independently increase AF risk. Additionally, increased clinical surveillance in anticoagulated patients may contribute to higher detection rates, while stronger signals for novel agents like edoxaban may reflect reporting bias.
Overall, this FAERS-based study highlights a significant AF safety signal with DOAC therapy, particularly with edoxaban. While these findings are hypothesis-generating, they emphasize the importance of careful cardiovascular monitoring, especially in elderly and high-risk populations. Further prospective and real-world studies are warranted to clarify causality and optimize the safety profile of DOACs in clinical practice.
Perspectives in Clinical Research
Disproportionality analysis of Atrial Fibrillation associated with Direct Oral Anticoagulants: A Pharmacovigilance study using the Food and Drug Administration Adverse Event Reporting System database
Shambhavi K et al.
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