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BRIEF RESEARCH REPORT article

Front. Pharmacol.
Sec. Obstetric and Pediatric Pharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1395982

Adverse Drug Reactions in Neonates: a brief view of the FDA Adverse Event Reporting System

Provisionally accepted
Pernille K. Byskov Pernille K. Byskov 1Christoffer S. Baden Christoffer S. Baden 1Jon Andersen Jon Andersen 1,2Espen Jimenez-Solem Espen Jimenez-Solem 1,2Ramus H. Olsen Ramus H. Olsen 1,2Christina Gade Christina Gade 1,2Ulrik Lausten-Thomsen Ulrik Lausten-Thomsen 3*
  • 1 Department of Clinical Pharmacology, Bispebjerg Hospital, Copenhagen, Denmark
  • 2 Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Capital Region of Denmark, Denmark
  • 3 Department of Intensive Care for Newborns and Infants, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

The final, formatted version of the article will be published soon.

    Introduction: Drug trials in neonates are scarce and consequently, neonates are at risks of adverse drug reactions (ADRs). Spontaneous ADR reporting is an important tool to expand knowledge and drug safety in neonates. This study explores the quality of the current neonatal ADR reports and the ADR reports of the most common drugs in the neonatal departments.Methods: An observational cross-sectional study focused on neonates, using data on spontaneous reports extracted from the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS) from Q3 2014 until December 2022. Only primary suspect drugs given to age <30 days were included in the analysis.Results: Spontaneous reports from 13 million patients of all ages, totaling 50 million adverse drug reactions (ADRs), were evaluated. Information regarding age was missing in 40% of the reports, and data on just 43,737 neonates with 948 different suspect drugs were identified and included in the analyses. We reported frequency of spontaneous ADR reports in the FAERS database for the ten most frequently administrated drugs at the US neonatal intensive care units.An overall underreporting of neonatal ADRs is still present. The FAERS database in this current form insufficiently discriminates between pre-and postnatal drug exposure. Improved systems for neonatal pharmacovigilance isare urgently needed An overall underreporting of neonatal ADRs is still present.

    Keywords: Pharmacology, Advers drug events, Neonatal pharmacology, Publich health, Pharmacovigilance

    Received: 04 Mar 2024; Accepted: 30 Apr 2024.

    Copyright: © 2024 Byskov, Baden, Andersen, Jimenez-Solem, Olsen, Gade and Lausten-Thomsen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Ulrik Lausten-Thomsen, Department of Intensive Care for Newborns and Infants, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.