Pediatric drug surveillance and the food and drug administration's adverse event reporting system: an overview of reports, 2003–2007

Authors

  • Rosemary Johann-Liang MD,

    Corresponding author
    1. Health Resources and Services Administration, Department of Health and Human Services, Rockville, MD, USA
    • Chief Medical Officer, National Vaccine Injury Compensation Program, Health Resources and Services Administration, Department of Health and Human Services, 5600 Fishers Lane, 11C-03 Rockville, MD 20857, USA.
    Search for more papers by this author
  • Jo Wyeth Pharm D,

    1. Division of Adverse Event Analysis, Office of Surveillance and Epidemiology, United States Food and Drug Administration, Silver Spring, MD, USA
    Search for more papers by this author
  • Min Chen MS, MPH,

    1. Division of Adverse Event Analysis, Office of Surveillance and Epidemiology, United States Food and Drug Administration, Silver Spring, MD, USA
    Search for more papers by this author
  • Judith U. Cope MD, MPH

    1. Office of Pediatric Therapeutics, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA
    Search for more papers by this author

Abstract

Purpose

Our objective was to examine the numbers and characteristics of US pediatric adverse events (AEs) reported to the Food and Drug Administration (FDA)'s adverse event reporting system (AERS) for 5 years following implementation of the Best Pharmaceuticals for Children Act (BPCA) in 2002.

Methods

We analyzed reports in AERS received by FDA from January 1, 2003 to January 1, 2008 for overall numbers, age, gender, and seriousness of outcome in children and adults. Pediatric and adult age groups (<2, 2–10, 11–17, 18–50, and >50 years of age) were further evaluated for most frequently reported suspect drug classes and AEs.

Results

Seventy-two percent of 815 267 crude count reports had specified age information. Six percent of the total reports with age information reported age <18 years. Numbers of AEs being reported for children have remained steady, while those for adults have increased. The proportion of serious AEs reported was similar for pediatrics as compared to adults. Frequently reported suspect drug classes noted in pediatric age groups that were not observed in adults included anticonvulsants, attention deficit hyperactivity disorder (ADHD), anti-acne, and respiratory medications.

Conclusions

This overview highlights the need for strengthening the passive drug surveillance system from a pediatric perspective, as well as investing in more active surveillance systems. Drug safety initiatives to better capture risk information in order to balance the risk/benefit of drug use in children. Copyright © 2008 John Wiley & Sons, Ltd.

Ancillary