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

Overview

Journal Pharmaceuticals (Basel)

Publisher MDPI

Specialty Chemistry

Date 2023 Nov 25

PMID 38004477

Authors

Chaerin Go

Semi Kim

Yujin Kim

Yongjun Sunwoo

Sae Hyun Eom

Jiseong Yun

Sooyoung Shin

Yeo Jin Choi

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

Antipsychotics and Risks of Cardiovascular and Cerebrovascular Diseases and Mortality in Dwelling Community Older Adults.

Perreault S, Boivin Proulx L, Brouillette J, Jarry S, Dorais M Pharmaceuticals (Basel). 2024; 17(2).

PMID: 38399393 PMC: 10892683. DOI: 10.3390/ph17020178.

References

Lasser K, Allen P, Woolhandler S, Himmelstein D, Wolfe S, Bor D . Timing of new black box warnings and withdrawals for prescription medications. JAMA. 2002; 287(17):2215-20. DOI: 10.1001/jama.287.17.2215. View

Kariki O, Kontonika M, Miliopoulos D, Bazoukis G, Vlachos K, Dragasis S . Contrast-induced early repolarization pattern and ventricular fibrillation. Clin Case Rep. 2021; 9(8):e04630. PMC: 8364931. DOI: 10.1002/ccr3.4630. View

Kornej J, Borschel C, Benjamin E, Schnabel R . Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circ Res. 2020; 127(1):4-20. PMC: 7577553. DOI: 10.1161/CIRCRESAHA.120.316340. View

Rabkin S . Impact of Age and Sex on QT Prolongation in Patients Receiving Psychotropics. Can J Psychiatry. 2015; 60(5):206-14. PMC: 4484689. DOI: 10.1177/070674371506000502. View

Doig J . Drug-induced cardiac arrhythmias: incidence, prevention and management. Drug Saf. 1997; 17(4):265-75. DOI: 10.2165/00002018-199717040-00006. View

Hamid A, Rahim R, Teo S . Pharmacovigilance and Its Importance for Primary Health Care Professionals. Korean J Fam Med. 2022; 43(5):290-295. PMC: 9532191. DOI: 10.4082/kjfm.21.0193. View

Shin J, Jung S, Ahn S, Lee S, Kim S, Seong J . New initiatives for pharmacovigilance in South Korea: introducing the Korea Institute of Drug Safety and Risk Management (KIDS). Pharmacoepidemiol Drug Saf. 2014; 23(11):1115-22. DOI: 10.1002/pds.3715. View

LaMori J, Mody S, Gross H, DiBonaventura M, Patel A, Schein J . Burden of comorbidities among patients with atrial fibrillation. Ther Adv Cardiovasc Dis. 2012; 7(2):53-62. DOI: 10.1177/1753944712464101. View

Killeen M . Drug-induced arrhythmias and sudden cardiac death: implications for the pharmaceutical industry. Drug Discov Today. 2009; 14(11-12):589-97. DOI: 10.1016/j.drudis.2009.03.004. View

10.

Li M, Ramos L . Drug-Induced QT Prolongation And Torsades de Pointes. P T. 2017; 42(7):473-477. PMC: 5481298. View

11.

Frommeyer G, Eckardt L . Drug-induced proarrhythmia: risk factors and electrophysiological mechanisms. Nat Rev Cardiol. 2015; 13(1):36-47. DOI: 10.1038/nrcardio.2015.110. View

12.

Scuderi P . Sevoflurane and QTc Prolongation: An Interesting Observation, or a Clinically Significant Finding?. Anesthesiology. 2010; 113(4):772-5. DOI: 10.1097/ALN.0b013e3181f2b088. View

13.

Vlachos K, Georgopoulos S, Efremidis M, Sideris A, Letsas K . An update on risk factors for drug-induced arrhythmias. Expert Rev Clin Pharmacol. 2015; 9(1):117-27. DOI: 10.1586/17512433.2016.1100073. View

14.

Morgovan C, Dobrea C, Chis A, Juncan A, Arseniu A, Rus L . A Descriptive Analysis of Direct Oral Anticoagulant Drugs Dosing Errors Based on Spontaneous Reports from the EudraVigilance Database. Pharmaceuticals (Basel). 2023; 16(3). PMC: 10056464. DOI: 10.3390/ph16030455. View

15.

Shin Y, Lee Y, Choi Y, Park B, Jee Y, Choi S . Spontaneous reporting of adverse drug events by Korean regional pharmacovigilance centers. Pharmacoepidemiol Drug Saf. 2009; 18(10):910-5. DOI: 10.1002/pds.1796. View

16.

Foster C, Griffin J . A comparison of the incidence of cardiac arrhythmias produced by two intravenous contrast media in coronary artery disease. Clin Radiol. 1987; 38(4):399-401. DOI: 10.1016/s0009-9260(87)80236-2. View

17.

Tisdale J, Chung M, Campbell K, Hammadah M, Joglar J, Leclerc J . Drug-Induced Arrhythmias: A Scientific Statement From the American Heart Association. Circulation. 2020; 142(15):e214-e233. DOI: 10.1161/CIR.0000000000000905. View

18.

Barnes B, Hollands J . Drug-induced arrhythmias. Crit Care Med. 2010; 38(6 Suppl):S188-97. DOI: 10.1097/CCM.0b013e3181de112a. View

19.

Jo H, Jeong K, Ryu J, Park S, Choi Y, Kwack W . Fatal Events Associated with Adverse Drug Reactions in the Korean National Pharmacovigilance Database. J Pers Med. 2022; 12(1). PMC: 8779892. DOI: 10.3390/jpm12010005. View

20.

Matucci A, Vultaggio A, Fassio F, Rossi O, Maggi E . Heart as the early main target of severe anaphylactic reactions: two case reports. Intern Emerg Med. 2010; 6(5):467-9. DOI: 10.1007/s11739-010-0482-6. View