Objective: To describe the suspected medications, types of reactions, and outcomes of adverse events (AEs) most commonly reported to the United States Food and Drug Administration (FDA) in children by age group.
Methods: All case reports submitted to the FDA Adverse Event Reporting System (FAERS) between January 1, 2007, and August 27, 2012, for children (1 to < 12 yrs) and adolescents (12 to < 18 yrs) were examined. The most commonly reported suspected drugs were ranked. The corresponding AEs with serious outcome were compared and described between age groups.
Results: We identified a total of 78,623 reports in the FAERS database (53.8% in children and 46.2% in adolescents). Serious outcomes were noted in 40% of the children and 43% of the adolescents. The proportion of all case reports for central nervous system stimulants (lisdexamfetamine, 69.8%; methylphenidate, 68.0%) and analgesics (ibuprofen, 72.3%; acetaminophen, 68.6%) was higher in children, whereas tumor necrosis factor blockers (infliximab, 78.2%; adalimumab, 77.1%), atypical antipsychotics (aripiprazole 52.7%; risperidone 58.3%; quetiapine 72.1%) and oral contraceptives (levonogrestrel, 99.2%; drospirenone and ethinyl estradiol, 97.9%) were more commonly reported in adolescents. For most drugs, the types of reactions reported were similar but had different rank order across age groups, with the most dissimilar profiles being observed for isotretinoin and aripiprazole.
Conclusions: This study highlights high-risk medications and their AE profiles in children and adolescents. Our findings underscore the need for further confirmation of particular drug and AE pairs and the heterogeneity of AEs by age.
Keywords: adolescents; adverse events; children; heterogeneity; postmarketing surveillance.
© 2014 Pharmacotherapy Publications, Inc.