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Overdose in young children treated with anti-reflux medications: Poisons enquiry evidence of excess 10-fold dosing

C Crawford1, M Anderson2, G Cooper3

  • 11 National Poisons Information Service - Edinburgh, Royal Infirmary of Edinburgh, Edinburgh, UK.

Human & Experimental Toxicology
|April 21, 2017
PubMed

Insights

Accidental overdoses in young children were common with ranitidine syrup, often tenfold the intended dose. Formulation changes are needed to improve medication safety for pediatric gastro-oesophageal reflux disease treatments.

Area of Science:

  • Pediatric Pharmacology
  • Toxicology
  • Drug Safety

Background:

  • Accidental drug overdose is a significant concern in young children.
  • Gastro-oesophageal reflux disease (GERD) treatments are frequently involved in pediatric overdoses.
  • The UK's National Poisons Information Service receives numerous enquiries regarding pediatric GERD medication overdoses.

Purpose of the Study:

  • To investigate the influence of drug formulation and dosage on overdose incidents in children under 5 years.
  • To compare overdose characteristics of ranitidine, omeprazole, and domperidone with metoclopramide and chlorphenamine.
  • To identify specific formulations and age groups at higher risk for accidental overdose.

Main Methods:

  • Retrospective analysis of UK National Poisons Information Service data from July 2007 to June 2015.
  • Comparison of overdose cases involving ranitidine, omeprazole, domperidone, metoclopramide, and chlorphenamine.
  • Stratification of cases by patient age (under 5 years, under 6 months) and overdose magnitude (e.g., tenfold).

Main Results:

  • Ranitidine accounted for a significant proportion of overdose enquiries in children under 5 years (77%).
  • Children under 6 months were disproportionately affected by ranitidine overdoses, with 79% of ranitidine overdose enquiries in this age group.
  • Tenfold overdoses were particularly noted with ranitidine in infants under 6 months (86 cases).

Conclusions:

  • High concentration of ranitidine syrup is a likely factor in tenfold overdoses in young children.
  • Liquid formulations for non-licensed indications in young children pose a risk for therapeutic errors.
  • Modifying drug formulations and enhancing prescriber/carer education are crucial to reduce pediatric medication errors and associated healthcare utilization.
Abstract

Keywords:
Paediatricdrug formulationpharmacovigilancepoisoningpoisons information

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