Evidence map›Paper›PMID 39775441›Full record

ArticleDrugs - real world outcomes2025

Medication Hazards and Outcome Patterns of Pediatric Drug-Associated Liver Injury in Taiwan: An Analysis of 1998-2017 Spontaneous Adverse Drug Reaction Reports.

Yu-Ting Huang, Yen-Ming Huang, Ni-Chung Lee, Ping-Ing Lee, Yunn-Fang Ho

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Article in Drugs - real world outcomes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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4 · The record

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5 · Who and what money

Authors and funding

5 authors.

Yu-Ting HuangSchool of Pharmacy, College of Medicine, National Taiwan University, Taipei, 100025, Taiwan.
Yen-Ming HuangSchool of Pharmacy, College of Medicine, National Taiwan University, Taipei, 100025, Taiwan.
Ni-Chung LeeDepartment of Pediatrics, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, 100226, Taiwan.
Ping-Ing LeeDepartment of Pediatrics, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, 100226, Taiwan.
Yunn-Fang HoSchool of Pharmacy, College of Medicine, National Taiwan University, Taipei, 100025, Taiwan. yfho@ntu.edu.tw.ORCID http://orcid.org/0000-0003-0579-8659

Funding

National Science and Technology Council NSTC 113-2320-B-002-051
6 · The paper itself

Abstract

BACKGROUND AND

objectivesAccumulating pediatric efficacy and safety data on drug use is inherently challenging yet essential. This study aimed to analyze the frequency and compute the odds of pediatric drug-associated liver injury across age groups (early childhood, middle childhood, and adolescence) and therapeutic categories using adverse drug reactions (ADRs) reporting data spanning nearly two decades.

methodsWe analyzed the reports of suspected ADRs occurring in children and adolescents in the Taiwan National Adverse Drug Reaction Reporting System during the period from May 1998 until July 2017. Standardized Medical Dictionary for Regulatory Activities Queries were utilized to identify suspected hepatic ADRs. Outcome patterns across age groups were compared using the chi-squared test, and disproportionality analysis was employed to calculate reporting odds ratios (RORs) of hepatic versus nonhepatic reports.

resultsAmong 16,673 reports, 484 (2.9%) were identified as suspected hepatic ADRs, involving 193 distinct drugs. The mean age of affected individuals was 8.2 years. Outcome types in adolescents were predominantly serious (91.8%). Antibacterials for systemic use (18.8%) and antiepileptics (8.7%) were the most frequently implicated therapeutic categories. Drugs with high ADR occurrence rates and significant RORs included oxacillin (5.2%; ROR: 12.07), methotrexate (4.1%; ROR: 9.07), and phenobarbital (2.7%; ROR: 5.04). Some medications exhibited higher ratios of used-versus-recommended doses, suggesting inappropriate dosing.

conclusionsPediatric drug-associated liver injury was not uncommon and may result in serious outcomes. This study underscores the need for heightened vigilance in administering certain high-risk drugs and attentiveness in proper dosing for children, including adolescents.

Identifiers

PMID39775441
PMCPMC11829874

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