Variable Effects of the COVID-19 Pandemic on Reported Adverse Events for Arrhythmic Activity and 30-Day Fills For Anti-Arrhythmic Agents

Abstract

- COVID-19 had large impacts on the lives of many individuals with rhythmical cardiac problems. With limitations that COVID-19 had on the ability to track medical based data, a controversy on the effect of COVID-19 on the incidence of arrhythmic activity has been apparent. To determine the effect that pandemic had on the incidence arrhythmic activity, we studied adverse event trends of 4 anti-arrhythmic agents — propafenone, sotalol, amiodarone, and dronedarone. Extracting data from the FDA FAERS database, we concluded significant (p<0.05) decreases for propafenone (55.8% decrease) and amiodarone and dronedarone (16.9% decrease) from 2020 to 2021 as well as an insignificant decrease for sotalol (30% decrease). In response to suggestive decreasing trends, we proceeded with a cost-analysis to explore possible reasons behind sudden decreases in reported adverse events. Using the Medicare Part D database, data for costs between generic vs. brand-name for previously examined antiarrhythmic agents as well as associations between 30-day fills and adverse event reports was examined. For each of the agents, the brand-name agents had a significantly higher cost than the brand-name agents. Associations between adverse events and 30-day fills were demonstrated through R2 values, which resulted in values of 0.238 for propafenone, 0.796 for sotalol, and 0.651 for amiodarone and dronedarone. We concluded that cost did not have a significant effect on adverse event reporting. Overall, we recommend further study into the potential underdiagnosis and undertreatment of cardiac arrhythmias during the COVID-19 pandemic, which can have dangerous implications on the long-term mortality of individuals without the appropriate materials. To accomplish this, it is necessary to analyze 2022 adverse event data for various anti-arrhythmic agents to observe new or continuing trends.