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Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
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Antibiotic-Induced Liver Injury in Paediatric Outpatients: A Case-Control Study in Primary Care Databases

Carmen Ferrajolo1,2, Katia M C Verhamme3, Gianluca Trifirò3,4

  • 1Department of Experimental Medicine, Pharmacology Section, Campania Regional Centre of Pharmacovigilance and Pharmacoepidemiology, University of Campania, Via Santa Maria di Costantinopoli, 16, 80138, Naples, Italy. carmen.ferrajolo@unina2.it.

Drug Safety
|December 28, 2016
PubMed

Insights

Antibiotic use in children is linked to a higher risk of liver injury. Certain antibiotics like ceftriaxone and cotrimoxazole pose a significant risk, even with short-term use.

Area of Science:

  • Pediatric pharmacology
  • Hepatology
  • Drug safety surveillance

Background:

  • Antibiotics are frequently prescribed for children.
  • Real-world data suggests a potential link between antibiotic exposure and acute liver injury in pediatric patients.

Purpose of the Study:

  • To evaluate the risk of liver injury associated with antibiotic use in pediatric outpatients.
  • To quantify the association between antibiotic exposure and liver injury in children and adolescents.

Main Methods:

  • A large-scale, population-based case-control study was conducted in Italy and The Netherlands (2000-2008).
  • Liver injury cases (<18 years) were identified and validated using CIOMS criteria.
  • Up to 100 controls were matched per case, with antibiotic exposure categorized as current, recent, or past use.
  • Multivariate conditional logistic regression analysis was employed to determine odds ratios (ORs).

Main Results:

  • 938 liver injury cases were matched with 93,665 controls.
  • Current antibiotic use showed a threefold increased risk of liver injury (adjusted OR: 3.22).
  • Significant risk increases were observed for specific antibiotics, with cotrimoxazole (OR: 24.16) and ceftriaxone (OR: 26.70) showing the highest risks.

Conclusions:

  • Antibiotic-induced liver injury in children is variable depending on the specific antibiotic.
  • Pediatricians must be aware of the liver injury risks associated with prescribing ceftriaxone, cotrimoxazole, and clarithromycin, even for brief durations.
Abstract

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