A neonatal acyclovir ROR of 939.92 is a signal, not a risk estimate
FAERS contained 130 neonatal reports and no exposed denominator. Its extreme infusion-site signal is a prompt for validation, not an estimate of how often harm occurs or proof that acyclovir caused it.
The hot take
A new FAERS analysis reported a 939.92 reporting odds ratio (ROR) for infusion-site necrosis or edema in neonatal acyclovir reports. That number is a disproportionality signal inside a spontaneous-report database, not evidence that an exposed infant faces 940 times the clinical risk. Its value is in choosing what to validate next.
Rates of occurrence cannot be established with reports.
He and colleagues retrospectively searched worldwide FAERS reports from 2004 through the third quarter of 2024. Eligible reports concerned neonates aged 28 days or younger and named acyclovir as the primary suspected drug. The team retained the latest version of duplicate case IDs, mapped events to MedDRA terms, and called a signal positive only when ROR, PRR, BCPNN, and EBGM criteria all agreed. Preferred-term signals also required at least three reports.
- 1
Collect reports
FAERS reports submitted worldwide from 2004 through 2024 Q3.
- 2
Filter neonatal cases
Age 28 days or younger, with acyclovir listed as the primary suspected drug.
- 3
Deduplicate and code
Keep the latest case version and map events to MedDRA preferred terms and system classes.
- 4
Intersect four algorithms
Require positive ROR, PRR, BCPNN, and EBGM results; preferred terms need at least three reports.
Was this worth carrying into your next shift?
Your reaction stays connected to your NICU360 profile.
Comments
0Join the conversation
Sign in to reply, vote, and keep your participation with your NICU360 profile.