Safety concerns of aztreonam: a real-world disproportionality analysis based on FDA Adverse Event Reporting System

Abstract

Background: Aztreonam was approved by the FDA for treating Gram-negative infections, including metallo-β-lactamase producers. This study extensively evaluated aztreonam-related adverse events (AEs) from the FDA Adverse Event Reporting System (FAERS) database for a better understanding of toxicities.

Methods: The signals of aztreonam-related AEs were quantified using disproportionality analyses, like reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker algorithms.

Results: Among the 18,182,912 records retrieved from the FAERS 11,627 cases were identified where aztreonam was the primary suspect drug. A total of 127 preferred terms with significant disproportionality that simultaneously met the criteria of all algorithms were retained. Unexpected safety signals such as cholestatic liver injury, hypoprothrombinemia, hemoptysis, pulmonary hemorrhage, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis and so on may also manifest in adults, particularly in elderly patients. The median onset time for AEs related to intravenous aztreonam was 4 days, compared to a year after the initiation of inhaled aztreonam.

Conclusions: Our study identified potential new adverse event signals and offered a thorough understanding of aztreonam's safety profiles. This information is crucial for enhanced cliggnical monitoring and risk assessment, aiding healthcare professionals in tailoring their approach.

Keywords: Aztreonam; FAERS; adverse events; pharmacovigilance.