Fatal Events Associated with Adverse Drug Reactions in the Korean National Pharmacovigilance Database

Abstract

Adverse drug reactions (ADRs) pose a global public health threat, substantially contributing to death. Due to the relative paucity of clinical evidence regarding fatal ADRs, this study was performed to characterize the epidemiology of fatal ADRs in Korea. This was a retrospective, cross-sectional analysis of ADR cases reported to the Korea Adverse Event Reporting System from 2010 to 2019. All ADRs were coded using the World Health Organization-Adverse Reaction Terminology system and classified as either fatal or non-fatal events. Logistic regression was performed to identify factors associated with fatal events. Among 289,756 ADR records, 629 fatal events (0.2%) occurred. The most common causative agent of fatal ADRs was antibacterials (20.3%), followed by antimycobacterials (5.4%), analgesics (4.0%), and contrast media (1.9%). Among antimicrobials, vancomycin was most frequently implicated without significantly increasing the risk of fatal events. The risk for fatal ADRs was significantly increased with male sex; advanced age; polypharmacy; piperacillin/β-lactamase inhibitor; cefotetan; ceftriaxone; combination antimycobacterial therapy consisting of rifampicin, isoniazid, pyrazinamide, and ethambutol; morphine; and iopromide (reporting odds ratio > 1, p < 0.05 for all). Although fatal ADRs are uncommon (<1%) in Korea, they are primarily caused by commonly used medications including antibiotics, analgesics, and contrast media.

Alergia a medicamentos: aspectos fundamentales en el diagnóstico y tratamiento

“…Aunque los medios de contraste yodados muestran una baja osmolaridad, su perfil de riesgo para reacciones adversas a medicamentos y de hipersensibilidad es considerable, pues ocurren en aproximadamente 3-30 y 1-3%, respectivamente, 86 en particular si existe el antecedente de hipersensibilidad relacionada con el medio de contraste. 87,88 Fisiopatología Todos los medios de contraste yodados comparten un núcleo común, llamado anillo de benceno triyodado. Se clasifican en monómeros o dímeros, según la cantidad de anillos (1 o 2) triyodados y si son iónicos o no iónicos.…”

“…Es posible que los medios de contraste yodados hiperosmolares y la presencia de una carga, que interrumpe el potencial eléctrico de la membrana celular, contribuyan con el aumento de la toxicidad observada con los agentes iónicos. 88,90…”

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“…WHO has launched programs targeting reduction of medication related harms [4]. A noxious and unintended response to medicinal products occurring at therapeutic doses is called adverse drug reaction (ADR) [5][6][7]. ADRs are common in healthcare settings and now pose a global public health threat [5].…”

“…A noxious and unintended response to medicinal products occurring at therapeutic doses is called adverse drug reaction (ADR) [5][6][7]. ADRs are common in healthcare settings and now pose a global public health threat [5]. They cause morbidity and mortality beside incurring additional cost [8].…”

Does every <i>Staphylococcus aureus</i> infection require anti-MRSA drugs? Three case reports of a <i>Staphylococcus aureus</i> infection

“…Compared to oxacillin or penicillin, vancomycin causes relatively more adverse reactions (9). The most serious adverse reactions can lead to death (10). Antimicrobial agents are the most common cause of drug reactions in the form of eosinophilia and systemic symptoms (DRESS), and vancomycin is responsible for about two-thirds of DRESS cases induced by antimicrobial agents (11).…”