Abstract
Introduction
The Food and Drug Administration Adverse Event Reporting System (FAERS) is a database of adverse event (AE) and medication error reports for drugs and therapeutic biologics. Examining trends of reported individual case safety reports (ICSRs) provides context for evaluating safety concerns.
Objective
Characterize pediatric FAERS ICSRs and compare trends (1) to adult reports; (2) within pediatric subgroups.
Methods
This cross-sectional study examined FAERS ICSRs received between January 1, 2010, through December 31, 2020. Stratified age bands were neonates, infants, younger children, older children, adolescents, and adults. We characterized groups by patient demographic information, suspect products, AEs, and reporter type.
Results
From 2010 to 2020, there were 11,258,995 FAERS ICSRs; 3.1% described pediatric patients. Compared to adults, pediatric ICSRs had higher proportions of all serious outcomes except death. Within pediatric subgroups, neonates had the highest proportions of serious outcomes (96.2%) compared to infants, younger children, older children, and adolescents (79.8%, 67.9%, 59.5%, and 52.7%, respectively). Younger pediatric age groups were more likely to have weight information than older age groups but were less likely to include gender information. The most frequently reported AE was off label use for pediatrics and drug ineffective for adults. Products and AEs reported also differed among pediatric subgroups. Neonates, infants, and adolescents had entirely distinct sets of top five product-event combinations.
Conclusion
Pediatric ICSRs represent a minority of FAERS reports but have distinctly different attributes relative to adult ICSRs. Reporting trends also vary within pediatric subgroups, which highlights the need for unique considerations for pediatric safety surveillance.
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Data Availability
FAERS data are available via the FAERS Public Dashboard and as Quarterly Data files. Additionally, individual case reports can be requested via a Freedom of Information Act request to the FDA. Additional details can be found at https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers.
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Funding
This project was supported in part by an appointment to the ORISE Research Participation Program at the CDER administered by the Oak Ridge Institute for Science and Education through an agreement between the US Department of Energy and the US Food and Drug Administration. Michael Phan and Vivian Dang conducted this research while they were ORISE fellows in the Office of Surveillance and Epidemiology, Center of Drug Evaluation and Research, FDA.
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All authors contributed to the study conception and design. Data collection and analysis were performed by MP, VD, and CC. The first draft of the manuscript was written by MP and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
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This is a public health surveillance activity and is granted an exemption from US FDA Institutional Review Board.
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Phan, M., Cheng, C., Dang, V. et al. Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010–2020: A Cross-Sectional Study. Ther Innov Regul Sci 57, 1062–1073 (2023). https://doi.org/10.1007/s43441-023-00542-0
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DOI: https://doi.org/10.1007/s43441-023-00542-0