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Published on: May 10, 2016

Individual case safety reports in children in commonly used drug groups - signal detection

Gertrud Brunlöf1, Carina Tukukino, Susanna M Wallerstedt

  • 1Department of Clinical Pharmacology and Regional Pharmacovigilance Centre, Sahlgrenska University Hospital, SE-413 45 Göteborg, Sweden. susanna.wallerstedt@pharm.gu.se

BMC Clinical Pharmacology
|March 28, 2008
PubMed

Insights

Pediatric drug safety knowledge is limited. This study found varying rates of adverse drug reactions, with a potential signal for montelukast (leukotriene receptor antagonist) and psychiatric effects in young children.

Area of Science:

  • Pediatric Pharmacology
  • Drug Safety Surveillance
  • Pharmacovigilance

Background:

  • Limited data exists on the safety of drug treatments in pediatric populations.
  • Enhanced understanding of pediatric drug risks is crucial for accurate risk-benefit assessments.

Purpose of the Study:

  • To investigate the types and frequency of adverse drug reactions (ADRs) in children.
  • To analyze safety reports for commonly prescribed drug classes in pediatric outpatients.

Main Methods:

  • Examined individual case safety reports (ICSRs) for the top 30 drug groups by defined daily doses (DDDs) in children (<15 years) in 2005.
  • Conducted descriptive analyses of reported adverse drug reactions.

Main Results:

  • ICSRs per million DDDs varied significantly across drug groups (0-24).
  • The highest rate was observed for montelukast (leukotriene receptor antagonist, R03DC).
  • Psychiatric adverse drug reactions were most frequent in children under 5 years treated with montelukast.

Conclusions:

  • The frequency of ICSRs per million DDDs differs among drug groups in pediatric patients.
  • A potential safety signal for montelukast associated with psychiatric adverse drug reactions in children warrants further investigation.
Abstract

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