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Disproportionality Analysis of Reporting Signals for Pericardial Disorders in the FDA Adverse Event Reporting System,
Kenneth L McCall1, Kristin T Bush1, Courtney E George1
1Binghamton University School of Pharmacy and Pharmaceutical Sciences, Department of Pharmacy Practice, Binghamton, United States of America.
Background/Objectives:
Pericardial syndromes cause significant morbidity, decreased quality of life, and rarely mortality. Drug-associated pericardial syndromes are underreported. This study characterized reports of pericardial disorders, described demographic and reporting features, and identified disproportionality signals across suspect drugs and therapeutic classes.
Methods:
This study analyzed FDA Adverse Event Reporting System reports from January 2000 to March 2025, using predefined preferred terms for pericardial syndromes. Duplicate and pediatric reports (<18 years) were excluded, resulting in 12,106 unique reports. A lower 90% confidence limit of the Empirical Bayes Geometric Mean (EB05)>2 and a lower limit of the 95% credibility interval of the Information Component (IC025)>0 were indicators of signals.
Results:
Raw counts of reports increased from 133 in 2000 to 939 in 2024. The cohort had a balanced sex distribution and a mean age of 55.5 years. Among females, antineoplastic (e.g., rituximab, EB05 = 13.3, IC025 = 3.7) and immunomodulating agents (e.g., adalimumab, EB05 = 3.1, IC025 = 1.6) were most frequently suspected. Among males, antithrombotic agents (e.g., aspirin, EB05 = 7.1, IC025 = 2.8) predominated. A higher age-adjusted reporting odds of death was observed in females versus males (OR=1.14, 95% CI 1.03-1.25; deaths: females n=1,030, males n=925).
Discussion:
Raw report counts of pericardial syndromes increased over 25 years, supporting heightened vigilance for drug-induced etiologies. Sex-stratified drug rankings were exploratory and do not demonstrate drug-by-sex interactions. The results extend the existing literature by providing a broad descriptive overview of the reporting landscape for pericardial disorders within a national spontaneous reporting system.
Conclusions:
Immunomodulating, antineoplastic, and antithrombotic agents generated reporting signals involving pericardial disorders, with sex-based differences and reported drug classes and outcomes. These findings do not establish causality and warrant confirmatory studies.