A Real-World Data Driven Pharmacovigilance Investigation on Drug-Induced Arrhythmia Using KAERS DB, a Korean Nationwide Adverse Drug Reporting System

This study aims to investigate the prevalence and seriousness of drug-induced arrhythmia and to identify predictors associated with the seriousness of arrhythmia. Drug-induced arrhythmia cases reported to the Korean Adverse Event Reporting System Database (KAERS DB) from January 2012 to December 202...

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Bibliographic Details
Published in:Pharmaceuticals (Basel, Switzerland) Switzerland), 2023-11, Vol.16 (11), p.1612
Main Authors: Go, Chaerin, Kim, Semi, Kim, Yujin, Sunwoo, Yongjun, Eom, Sae Hyun, Yun, Jiseong, Shin, Sooyoung, Choi, Yeo Jin
Format: Article
Language:English
Subjects:
adverse drug events
Aging
Analgesics
Anesthesia
Anti-arrhythmia drugs
Antibiotics
arrhythmia
Cancer
Cardiac arrhythmia
Chemotherapy
Clinical outcomes
Comorbidity
Contrast agents
Contrast media
Development and progression
drug safety
Ethnicity
Fentanyl
Heart failure
KAERS DB
Mortality
Narcotics
Oncology, Experimental
Patients
Pharmacovigilance
Product safety
RWD
Womens health
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Summary:This study aims to investigate the prevalence and seriousness of drug-induced arrhythmia and to identify predictors associated with the seriousness of arrhythmia. Drug-induced arrhythmia cases reported to the Korean Adverse Event Reporting System Database (KAERS DB) from January 2012 to December 2021 were investigated. A disproportionality test was performed to detect the association of the etiologic medication classes and types, along with patient demographic information, with the seriousness of drug-induced arrhythmia. Logistic regression was performed to investigate the predictors that increase the risk of serious arrhythmia. The most common etiologic agent for drug-induced arrhythmia was sevoflurane, whereas serious arrhythmia was most prevalent with narcotics. Antibiotics (reporting odds ratio (ROR) 4.125; 95% CI 1.438–11.835), chemotherapy (ROR 6.994; 95% CI 2.239–21.542), and iodinated contrast media (ROR 8.273; 95% CI 3.062–22.352) had a strong association with the seriousness of drug-induced arrhythmia. Among numerous etiologic agents, ioversol (ROR 16.490; 95% CI 3.589–75.772) and lidocaine (ROR 12.347; 95% CI 2.996–50.884) were more likely to be reported with serious arrhythmia. Aging and comorbidity, primarily cancer, are the most contributing predictors associated with serious arrhythmia. Further studies on the clinical significance of patient-specific predictors for the increased risk of serious drug-induced arrhythmia are warranted to promote drug safety.
ISSN:1424-8247
1424-8247
DOI:10.3390/ph16111612