Pediatric drug surveillance and the food and drug administration's adverse event reporting system: an overview of reports, 2003–2007
Article first published online: 13 NOV 2008
Copyright © 2008 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 18, Issue 1, pages 24–27, January 2009
How to Cite
Johann-Liang, R., Wyeth, J., Chen, M. and Cope, J. U. (2009), Pediatric drug surveillance and the food and drug administration's adverse event reporting system: an overview of reports, 2003–2007. Pharmacoepidem. Drug Safe., 18: 24–27. doi: 10.1002/pds.1679
- Issue published online: 29 DEC 2008
- Article first published online: 13 NOV 2008
- Manuscript Accepted: 6 OCT 2008
- Manuscript Revised: 18 SEP 2008
- Manuscript Received: 16 APR 2008
- drug safety;
- drug surveillance;
- adverse events;
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.
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.
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.
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.