Adverse events associated with use of immunoglobulin in pediatric patients reported to the US Food and Drug Administration Adverse Event Reporting System, 2001–2023

Key Points

• To evaluate the safety profile of immunoglobulin in pediatric patients based on FDA adverse event reports.
• Analysis of adverse event reports from the FDA Adverse Event Reporting System between 2001 and 2023
• Assessment of safety profile consistency with prelicensure studies and package insert data
• Identification of limitations like passive surveillance and absence of exposure denominators
• No new safety concerns identified regarding immunoglobulin in pediatric use
• Safety profile aligns with existing clinical data from prelicensure studies
• Reports of adverse events were consistent with information provided in package inserts