Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010-2020: A Cross-Sectional Study.

Michael T Phan Carmen Cheng Vivian Dang Eileen Wu Monica A Muñoz

Published in: Therapeutic innovation & regulatory science (2023)

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.

Keyphrases

adverse drug
childhood cancer
drug administration
emergency department
public health
risk assessment
drug induced