Safety and Tolerability of Inhaled Aztreonam in Children and Adolescents: A Systematic Review and Meta-Analysis.

Abstract

Respiratory infections and chronic lung disease are major contributors to morbidity in children. Aztreonam lysine for inhalation (AZLI) delivers high local antibiotic concentrations while limiting systemic exposure; however, its safety in younger patients remains uncertain. This systematic review and meta-analysis searched MEDLINE, CENTRAL, and Google Scholar for randomized and observational studies reporting adverse events in children and adolescents (≤18 years) receiving AZLI, with no date limit. Fourteen studies were included. Most studies were moderate-to-high quality. Comparative analysis showed no clinically relevant increase in common adverse events relative to placebo or other inhaled antibiotics. The pooled relative risk for severe respiratory disorders (grade 3/4) was 1.65 (95% CI 1.07-2.57), suggesting a higher incidence of serious respiratory events, while a protective effect against decline in pulmonary function was observed (RR 0.70, 95% CI 0.54-0.90). Adverse events were generally mild; serious adverse events and hospitalizations were infrequent and comparable between groups. Cumulative prevalence estimates indicated that respiratory irritation occurred in 10-25% of patients, whereas systemic effects were uncommon. Overall, AZLI appears to have an acceptable tolerability and safety profile in children and adolescents, though careful monitoring is warranted, especially for severe respiratory events.