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

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 (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