학술논문
Adverse drug reactions in neonates: a brief analysis of the FDA adverse event reporting system
Document Type
article
Author
Source
Frontiers in Pharmacology, Vol 15 (2024)
Subject
Language
English
ISSN
1663-9812
Abstract
IntroductionDrug trials in neonates are scarce, and the neonates may consequently be at risk of adverse drug reactions (ADRs). Spontaneous ADR reporting is an important tool for expanding the knowledge on drug safety in neonates. This study explores the quality of current neonatal ADR reports and the ADR reports of the most common drugs used in neonatal departments.MethodsAn observational cross-sectional study focused on neonates was conducted using data on spontaneous reports extracted from the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS) from the third quarter of 2014 up to December 2022. Only the primary suspect drugs given to neonates or subjects aged