Abstract 14453: Risk of Atrial Fibrillation (AF) With Radiation Therapy Compared to Known Drugs Causing AF: Data From the FDA Adverse Event Reporting System, a Pharmacovigilance Database

Abstract

Introduction: Even though some studies have implicated radiation therapy (RT) as a risk factor for atrial fibrillation (AF), the association between RT and AF remains controversial. Hypothesis: To estimate the risk of AF associated with RT and compare it with dobutamine, flecainide, propafenone, ibrutinib and adenosine - the most common drugs causing AF. Methods: The US Food and Drug Administration’s Adverse Event Reporting System (FAERS) was queried for “Atrial fibrillation (AF)” secondary to “radiation therapy”, “Dobutamine”, “dobutamine hydrochloride”, “dobutamine hydrochloride in dextrose”, “flecainide”, “flecainide acetate”, “propafenone”, “propafenone hcl”, “propafenone hydrochloride”, “propafenone hydrochloride sr”, “ibrutinib” and “adenosine” and all other drugs on May 25, 2021. Disproportionality signal analysis was performed by calculating the reporting odds ratio (ROR) with its 95% confidence interval (CI). The ROR was considered significant when the lower limit of the 95% CI was >1.0. Results: FAERS database has a total of 22,002,078 AE reported till May 25, 2021. The ROR (95% CI) for AF due to RT versus all other drugs in FAERS was 3.9 (2.9 to 5.3) signifying disproportionately increased reporting. ROR (95%CI) for AF due to dobutamine, flecainide, propafenone, ibrutinib and adenosine was 18.2 (15.6 to 21.3), 19.0 (17.0 to 21.2), 35.9 (32.5 to 39.7), 16.6 (15.9 to 17.4) and 10.0 (7.4 to 13.6) respectively. Conclusions: While there is significantly higher reporting of AF with RT, this risk is lower when compared to the most common causes of drug induced AF.