Analysis of the US FDA adverse event reporting system to identify adverse cardiac events associated with hydroxychloroquine in older adults

Abstract

Purpose: The purpose of this study is to analyze the US FDA Adverse Event Reporting System (FAERS) to identify adverse cardiac events of hydroxychloroquine in older adults. Method: A case/non-case method was used to determine adverse events associated with hydroxychloroquine as the primary suspect drug between January 1, 2004, and December 31, 2019, for older adults (≥65 years). Adverse events are preferred terms (PTs) defined in MedDRA. We used frequentist approaches, including the reporting odds ratio (ROR) and the proportional reporting ratio (PRR) to measure disproportionality. We used Bayesian approaches to derive information component (IC) value and Empirical Bayesian Geometric Mean (EBGM) score. Signals were defined as the number of reports > 3 and the lower limit of 95% confidence intervals (CI) of ROR ≥ 2, PRR ≥ 2, IC > 0, EBGM > 1. Results: We identified 334 adverse cardiac events comprising 71 different MedDRA PTs from 2004 to 2019 for hydroxychloroquine in older adults. Strong disproportionality signals were noted for "Restrictive cardiomyopathy" (ROR = 272.43

Antibacterial‐associated acute kidney injury among older adults: A post‐marketing surveillance study using the FDA adverse events reporting system

“…Similarly, an earlier study by Van Puijenbroek et al 43 found out that both PRR and ROR detected more disproportionate signals than IC. However, our study used more stringent thresholds for the frequentist methods (PRR and ROR lower 95% confidence interval of at least 2.0), consistent with recently published literature 44 . Our findings show that with improved signal detection thresholds, the specificity for frequentist methods can be improved (Table 2).…”

Antimalarials exert a cardioprotective effect in lupus patients: Insights from the Spanish Society of Rheumatology Lupus Register (RELESSER) analysis of factors associated with heart failure

“…Although hydroxychloroquine and chloroquine are generally well-tolerated, they can have severe cardiologic adverse effects, including cardiomyopathy and conduction defects [13] . Furthermore, a recent survey from the United States Food and Drug Administration Adverse Event Reporting System indicated a relatively high risk of cardiomyopathy and myocardial disorders following exposure to hydroxychloroquine in older adults [21] . In contrast, the use of antimalarials was associated with a lower prevalence of CHF in our large multicenter retrospective SLE cohort, and, interestingly, this effect occurred independently of disease severity.…”