A real-world disproportionality analysis of Amiodarone: data mining of the public version of FDA adverse event reporting system

Abstract Background: Amiodarone is a class III antiarrhythmic medication used to treat arrhythmias for decades. The objective of this study was to enhance the current understanding of adverse events (AEs) associated with Amiodarone by employing data mining methods on the US Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: The AE records were selected by searching the FDA Adverse Event Reporting System database from September 2014 to September 2023. The disproportionality analysis algorithms, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN) and empirical Bayes geometric mean (EBGM) were used to detected signals of Amiodarone-related adverse events. Results: Among 8,595,344 reports, 7,841 specifically mentioned Amiodarone use, with the majority of AEs occurring in males over 60 years old. The United States was responsible for the highest proportion of reported AEs. Reports of severe outcomes, including hospitalization, life-threatening events and death, were notable. Significant system organ classes (SOC) included “Cardiac disorders” (SOC: 10007541), “Respiratory, thoracic and mediastinal disorders” (SOC: 10038731), and “Metabolism and nutrition disorders” (SOC: 10027433), etc. The significant AEs were then mapped to preferred terms such as “myxoedema coma” (n=108, EBGM05=499.73), “thyrotoxic crisis” (n=97, EBGM05=194.83), and “mitochondrial aspartate aminotransferase increased ” (n=8，EBGM05=186.19)，which have emerged in the study usually reported in patients with Amiodarone. Of note, unexpected significant AEs, including “thyroiditis” (n=161, EBGM05=127), “electrocardiogram T wave alternans” (n=13, EBGM05=236.29) and “iodine overload” (n=5, EBGM05=152.03), were uncovered in the label. Conclusions: These findings underscore the significance of vigilantly monitoring and comprehending the potential risks linked to Amiodarone use. Unexpected AEs discovered made a thorough understanding of the drug, which is essential for clinicians to ensure safe use of Amiodarone.