Safety analysis of acyclovir use in neonates based on the FDA Adverse Event Reporting System
Longbing He, Bo Wang, Yang Wang, Youshuai Chen · 2026
Read Safety analysis of acyclovir use in neonates based on the FDA Adverse Event Reporting System by Longbing He, Bo Wang, Yang Wang, Youshuai Chen (2026) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/PMC13529189.txt.
Description
He and colleagues mined the Food and Drug Administration's adverse event database for safety signals of acyclovir, in a 2026 analysis. Acyclovir is the first-line drug for herpes simplex infection in newborns. Safety evidence in babies under one month old is thin despite wide use at high doses. The team screened reports from 2004 through late 2024 with acyclovir as the suspect.
He found 130 neonatal reports covering 409 adverse events and applied four statistical signal methods at once, keeping only signals positive on all four. Four organ groups stood out: skin and tissue under it, general and injection-site problems, liver and bile disorders, and kidney and urinary disorders. The strongest signals involved tissue death or swelling at the infusion site and skin peeling or death. Three reported events, including Kawasaki disease and gut inflammation, do not appear in product labeling, which the authors say warrants confirmation and monitoring.
Catalog record
| CREATOR | Longbing He, Bo Wang, Yang Wang, Youshuai Chen |
|---|---|
| YEAR | 2026 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 28 KB |
| LICENSE | https://creativecommons.org/licenses/by/4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |