Pediatrics and neonatology · 2026
Drug-associated severe cutaneous adverse events in infants: Results of a disproportionality analysis from the USFDA adverse event reporting system.
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Sridharan Kannan, Sivaramakrishnan Gowri
Аннотация
BACKGROUND: Severe cutaneous adverse events (SCAEs) in infants are rare but they can be life-threatening. Despite the increased susceptibility of infants to adverse drug reactions, there are limited data on drug-associated SCAEs in this population. This study aimed to identify drugs associated with SCAEs in infants using the USFDA Adverse Event Reporting System (AERS) through disproportionality analysis.
METHODS: Data from 82 quarters (March 2004 to June 2024) were extracted from the USFDA AERS. Severe cutaneous reactions were identified using the Standardized MedDRA Query (SMQ) for "severe cutaneous adverse reactions," and relevant Preferred Terms (PTs). Reports involving infants (aged ≤1 year) were included. Frequentist and Bayesian methods were used for identifying signals between drugs and SCAEs. Demographic data and outcomes, including death, disability, and hospitalization, were also analyzed.
RESULTS: Out of 29,153,222 reports, 266 qualified for inclusion. Significant associations were found between SCAEs and drugs including beta-lactam and non-beta-lactam antibiotics, acetaminophen, phenytoin, and rasburicase. Unexpected signals were detected for nirsevimab, oseltamivir, anakinra, and acetaminophen. A male preponderance was observed in most SCAEs except for drug reaction with eosinophilia and systemic symptoms, which showed a female bias. Toxic epidermal necrolysis was associated with higher mortality compared to other SCAEs.
CONCLUSION: This study highlights the diverse range of drugs associated with SCAEs in infants and it underscores the importance of vigilance in drug safety monitoring. The identification of emergent drug-event associations provides critical insights for clinical practice and pharmacovigilance.
METHODS: Data from 82 quarters (March 2004 to June 2024) were extracted from the USFDA AERS. Severe cutaneous reactions were identified using the Standardized MedDRA Query (SMQ) for "severe cutaneous adverse reactions," and relevant Preferred Terms (PTs). Reports involving infants (aged ≤1 year) were included. Frequentist and Bayesian methods were used for identifying signals between drugs and SCAEs. Demographic data and outcomes, including death, disability, and hospitalization, were also analyzed.
RESULTS: Out of 29,153,222 reports, 266 qualified for inclusion. Significant associations were found between SCAEs and drugs including beta-lactam and non-beta-lactam antibiotics, acetaminophen, phenytoin, and rasburicase. Unexpected signals were detected for nirsevimab, oseltamivir, anakinra, and acetaminophen. A male preponderance was observed in most SCAEs except for drug reaction with eosinophilia and systemic symptoms, which showed a female bias. Toxic epidermal necrolysis was associated with higher mortality compared to other SCAEs.
CONCLUSION: This study highlights the diverse range of drugs associated with SCAEs in infants and it underscores the importance of vigilance in drug safety monitoring. The identification of emergent drug-event associations provides critical insights for clinical practice and pharmacovigilance.