Identification of suspected fatal adverse drug reactions by paediatricians: a UK surveillance study

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K Cheng1, S Masters, T Stephenson

  • 1Centre for Reproduction and Early Life, Academic Division of Child Health, School of Human Development, Queen's Medical Centre, Nottingham NG7 2UH, England.

Archives of Disease in Childhood
|June 26, 2007
PubMed

Insights

This study investigated fatal adverse drug reactions (ADRs) in children. While most reported deaths were not drug-related, under-reporting of serious ADRs in children remains a concern.

Area of Science:

  • Pediatric Pharmacology
  • Drug Safety Surveillance
  • Clinical Pediatrics

Background:

  • Concerns regarding under-reporting of serious adverse drug reactions (ADRs) in children prompted this British Paediatric Surveillance Unit (BPSU) study.
  • The Yellow Card Scheme is a key mechanism for ADR reporting in the UK and Ireland.

Observation:

  • A 13-month surveillance period (June 2002-June 2003) involved monthly mailings to paediatricians across the UK and Ireland.
  • Seven reports meeting study criteria for fatal ADRs in children under 16 were received.
  • An independent panel assessed causality using formal criteria, with consensus not reached in two cases.

Findings:

  • Five of the seven reported deaths were deemed unlikely to be causally related to the drug by the expert panel.
  • Causality assessments for the remaining two deaths varied from possible to certain.

Implications:

  • The study suggests no major public health concern regarding fatal ADRs in children based on the observed data.
  • Limitations indicate potential for unrecognised or unreported fatal ADRs in pediatric populations.
  • Further research may be needed to fully understand the scope of fatal ADRs in children.

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