FAERS analysis identifies pediatric severe-anaphylaxis drug reporting signals

Researchers analyzed pediatric adverse-event reports submitted to the FDA Adverse Event Reporting System (FAERS) from the first quarter of 2004 through the fourth quarter of 2023. They applied five signal-detection methods, including reporting odds ratios and Bayesian approaches, to identify drugs associated with reports of severe anaphylaxis. The study did not provide the total number of reports analyzed or the age-group denominators in the supplied text.

The analysis identified 138 positive drug signals. Anti-infective drugs accounted for the most reports overall, with 845 cases. Among the 30 most-reported drugs, ibuprofen had 369 reports; ceftriaxone was associated with the highest number of reported deaths. Infliximab and omalizumab were also among the drugs with the most reports. The authors noted signals involving human normal immunoglobulin and sevoflurane, whose product instructions they said did not mention severe-anaphylaxis adverse reactions. Reported outcomes were poorer in younger children.

These findings identify reporting patterns, not comparative risks: FAERS reports are voluntary and lack the exposure denominators needed to estimate incidence or establish causation. The results support further investigation and should not be interpreted as evidence to change prescribing on their own.