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Pharmacovigilance practice on off-label high-dose of vancomycin in severely ill children

Min Qin1, Wenwen Chen1, Bin Lu2

  • 1Department of Pharmacy, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.

Frontiers in Pharmacology
|September 26, 2025
PubMed

Insights

High-dose vancomycin in critically ill children poses a risk of kidney injury. Implementing enhanced monitoring and individualized dosing strategies significantly reduced adverse events in a pediatric intensive care unit.

Area of Science:

  • Pediatric Critical Care Medicine
  • Pharmacology
  • Nephrology

Background:

  • Off-label high-dose vancomycin is used in severely ill children.
  • Vancomycin dosing requires careful consideration due to potential toxicity.
  • Pediatric Intensive Care Units (PICUs) face challenges in managing high-dose antibiotic regimens.

Purpose of the Study:

  • To assess the safety of off-label high-dose vancomycin in critically ill children.
  • To identify strategies for mitigating risks associated with high-dose vancomycin therapy.
  • To evaluate the impact of improved monitoring on vancomycin-related adverse events.

Main Methods:

  • A retrospective case-control study analyzed vancomycin treatment in 39 PICU patients.
  • Investigated a case of acute kidney injury linked to off-label high-dose vancomycin ( > 40 mg/kg/day).
  • Implemented interventions including enhanced trough concentration monitoring and individualized dosing.

Main Results:

  • 51.3% of patients received off-label high-dose vancomycin.
  • 25% of those on high-dose vancomycin experienced adverse reactions, including severe cases.
  • Following intervention implementation, no vancomycin-associated acute kidney injury cases were observed in 86 treated children.

Conclusions:

  • High-dose vancomycin in severely ill children carries a risk of renal impairment.
  • Enhanced therapeutic drug monitoring and individualized regimens are crucial for safe vancomycin use.
  • Proactive clinical medication safety practices are essential for preventing vancomycin-induced nephrotoxicity.
Abstract

Keywords:
acute kidney injurychildoff-labelpharmacovigilancevancomycin

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