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Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
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Trimethoprim-Sulfamethoxazole Associated Drug-Induced Liver Injury in Pediatrics: A Systematic Review

Rodrigo M Burgos1, Kate M Reynolds2, Jean Williams2

  • 1From the Department of Pharmacy Practice, Section of Infectious Diseases Pharmacotherapy.

The Pediatric Infectious Disease Journal
|April 14, 2020
PubMed

Insights

Trimethoprim-sulfamethoxazole (TMP-SMX) may cause drug-induced liver injury (DILI) in children, with observational studies showing mild effects and case reports indicating severe outcomes. Further research is needed to clarify this association.

Area of Science:

  • Pediatric Pharmacology
  • Hepatology
  • Adverse Drug Reactions

Background:

  • Drug-induced liver injury (DILI) is a known adverse event of trimethoprim-sulfamethoxazole (TMP-SMX) in adults.
  • Limited data exists on the association between TMP-SMX and DILI in pediatric populations.
  • This systematic review investigates the risk of DILI in children exposed to TMP-SMX.

Purpose of the Study:

  • To systematically review and synthesize existing evidence on the association between TMP-SMX and DILI in pediatric patients.
  • To evaluate the spectrum and severity of hepatic adverse events linked to TMP-SMX in children.

Main Methods:

  • A comprehensive literature search was conducted across multiple databases (PubMed, Medline, Embase, Cochrane, Scopus, Web of Science).
  • Studies including pediatric patients (≤18 years) with hepatic adverse events following TMP-SMX exposure were included.
  • The Naranjo scale was utilized to assess causality in case reports.

Main Results:

  • Twenty-two studies were analyzed, comprising randomized trials, observational studies, and case reports.
  • Mild, transient hepatic function abnormalities were noted in randomized trials and prospective studies.
  • Retrospective studies indicated a statistically significant increased odds of DILI with TMP-SMX use and reported one fatal case; case reports suggested both mild and severe liver outcomes.

Conclusions:

  • The evidence linking TMP-SMX to DILI in pediatrics is currently limited.
  • While observational studies suggest mild hepatic abnormalities, case reports point towards potentially severe manifestations.
  • Additional research is warranted to fully elucidate the association between TMP-SMX and DILI in the pediatric population.
Abstract

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