To address concerns related to the safety profile of both Food and Drug Administration (FDA)–approved and non-FDA-approved intranasal corticosteroid (INCS) use in the pediatric population.
Data Source
Systematic review of MEDLINE, PubMed, and EMBASE databases using comprehensive search strategy, including all INCS formulations and adverse events. The study design was developed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Additional sources were identified from study references of relevant articles.
Review Methods
A structured literature search was conducted. Extracted data included age, population size, study design, drug (dosage, route, and frequency), presence of hypothalamic-pituitary-adrenal (HPA) axis suppression, ocular symptoms, and growth velocity adverse events.
Results
A total of 33 studies met inclusion criteria. The studies included use of INCS as nasal sprays and drops. There were no persistent abnormalities noted in cortisol level or intraocular pressure change. Growth velocity reduction was reported in 3 of 10 randomized trials. Meta-analysis of epistaxis and headache showed no significant difference in the incidence of headache or epistaxis when FDA-approved INCSs were compared to placebo, with a relative risk of 1.12 (95% CI, 0.77-1.63; P = .56) and 0.84 (95% CI, 0.60-1.18; P = .32), respectively. Meta-analysis was not performed for growth velocity, HPA axis suppression, and ocular change.
Conclusions
INCSs in FDA-approved routes of administration are generally safe to use in the pediatric population. Use of non-FDA-approved INCS drops may increase risk of iatrogenic Cushing’s syndrome. Growth velocity reduction, HPA axis suppression, and visual changes due to INCS are uncommon.
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