Risk of drug-induced delirium in older patients- a pharmacovigilance study of FDA adverse event reporting system database

Abstract

ABSTRACT Background Drug-induced delirium is one of the numerous known risk factors associated with increased morbidity and mortality in older patients. The objective of this study was to evaluate the risk of drug-related delirium in older patients based on the FDA Adverse Event Reporting System (FAERS). Research design and methods Delirium reports in older patients (age ≥65) from 2004 quarter 1 through 2021 quarter 3 extracted from the FAERS database using Open Vigil 2.1. The reported odds ratio and the proportional r7eported ratio were calculated to detect the adverse reaction signal of delirium. Combined with published evidence, suspected drugs were categorized as known, possible, or new potential delirium-risk-increasing drugs. Results Of the 130,885 reports (including 28,850 delirium events and 1,857 drug) analyzed for this study, 314 positive signal drugs were detected. Positive signal drugs are mainly concentrated on the drug of nervous system [n = 149, ROR 3.60, 95% CI (3.56–3.64)], cardiovascular system [n = 35, ROR 1.45, 95% CI (1.43–1.47)], alimentary tract and metabolism [n = 35, ROR 1.25, 95% CI (1.23–1.26)] and anti-infectives for systemic use [n = 27, ROR 1.70, 95% CI (1.66–1.74)]. Of the positive signal drugs, 26.11% (82/314) were known delirium-risk increasing drugs [ROR 4.12, 95%CI (3.85–4.41)], 44.90% (141/314) were possible [ROR 3.59, 95%CI (3.37–3.83)] and 28.98% (91/314) were new potential [ROR 3.68, 95%CI (3.22–4.21)]. Conclusion Drug-induced delirium risk is prevalent in the older patients according to the FAERS. The risk level of drug-induced delirium should be taken into account to optimize drug therapy in clinical practice.