Evaluating adverse events of antibacterials in infants: insights from FDA adverse event reporting system (FAERS) data

Area of Science:

• Pharmacovigilance
• Pediatric Pharmacology
• Drug Safety

Background:

• Infants (0-1 year) are a vulnerable population for drug-induced adverse events.
• Limited pharmacovigilance data exists for commonly used antibacterials in this age group.
• Antibacterial drug safety evaluations are crucial for optimizing pediatric treatment.

Purpose of the Study:

• To retrospectively assess adverse events (AEs) associated with vancomycin, cefotaxime, and gentamicin in infants (0-1 year).
• To identify specific safety signals for these antibacterials using pharmacovigilance data.
• To evaluate the risk-benefit profile of these drugs in a vulnerable infant population.

Main Methods:

• Utilized FDA Adverse Event Reporting System (FAERS) data from 2005Q1 to 2025Q1.
• Conducted disproportionality analyses including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPN), and Multi-item Gamma Poisson Shrinker (MGPS).
• Applied multiple testing correction with a 5% false discovery rate and Weibull distribution analysis for AE onset timing.

Main Results:

• Significant AE signals were detected for vancomycin and gentamicin, primarily linked to acute kidney injury.
• Cefotaxime showed associations with elevated alanine and aspartate aminotransferase levels, indicating potential liver injury.
• Gentamicin was also linked to neurosensory deafness, and AE risk remained consistent over time for all three drugs.

Conclusions:

• Vancomycin, cefotaxime, and gentamicin are associated with significant adverse events in infants, highlighting their vulnerability to drug toxicity.
• Findings underscore the critical need for individualized risk-benefit assessments before prescribing these antibacterials to infants.
• This study emphasizes the importance of ongoing pharmacovigilance for pediatric drug safety.