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Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from
Michael Phan1,2, Carmen Cheng3, Vivian Dang1
1Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
Insights
Pediatric reports in the Food and Drug Administration Adverse Event Reporting System (FAERS) show higher serious outcomes than adults. Trends vary significantly within pediatric subgroups, necessitating tailored safety surveillance.
Area of Science:
- Pharmacovigilance
- Pediatric drug safety
- Adverse event analysis
Background:
- The Food and Drug Administration Adverse Event Reporting System (FAERS) collects individual case safety reports (ICSRs) for drugs and biologics.
- Analyzing FAERS ICSR trends provides crucial context for evaluating drug safety concerns.
Purpose of the Study:
- To characterize pediatric FAERS ICSRs.
- To compare pediatric ICSR trends with adult reports.
- To analyze trends within pediatric subgroups.
Main Methods:
- A cross-sectional study of FAERS ICSRs from January 1, 2010, to December 31, 2020.
- Stratification of patients into age bands: neonates, infants, younger children, older children, adolescents, and adults.
- Characterization by patient demographics, suspect products, adverse events (AEs), and reporter type.
Main Results:
- Pediatric ICSRs constituted 3.1% of the total 11,258,995 FAERS reports (2010-2020).
- Pediatric ICSRs exhibited higher proportions of serious outcomes (excluding death) compared to adults.
- Neonates showed the highest proportion of serious outcomes (96.2%), with significant variations across pediatric subgroups.
- Reported products and AEs differed notably among pediatric subgroups, with distinct top product-event combinations for neonates, infants, and adolescents.
Conclusions:
- Pediatric ICSRs in FAERS, though a minority, possess distinct attributes compared to adult reports.
- Significant variations in reporting trends exist within pediatric subgroups.
- These findings underscore the necessity for specialized approaches to pediatric safety surveillance.
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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