Intranasal Corticosteroid Therapy: Systematic Review and Meta-analysis of Reported Safety and Adverse Effects in Adults

Otolaryngol Head Neck Surg. 2020 Dec;163(6):1097-1108. doi: 10.1177/0194599820931455. Epub 2020 Jun 16.

Abstract

Objectives: 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 adult population.

Data source: Systematic review of MEDLINE, PubMed, and EMBASE databases using a 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. Each study was graded for level of evidence using the Oxford Centre for Evidence-Based Medicine. Extracted data included population size, study design, drug (dosage, route, and frequency), presence of hypothalamus pituitary axis suppression, ocular symptoms, and treatment-related adverse events.

Results: A total of 60 studies met inclusion criteria. The studies included use of INCS as metered nasal sprays, drops, injections, aerosols, and irrigations. There were no persistent abnormalities in cortisol level or intraocular pressure change. Meta-analysis of epistaxis showed a significantly increased risk in the FDA-approved treatment group in comparison with control (risk ratio 1.56; 95% confidence interval, 1.13-2.14; P = .007).

Conclusions: Overall, it appears that the use of both FDA and published non-FDA application of INCS are safe in the adult population. Meta-analysis demonstrated an increased risk of epistaxis in patients using INCS compared with placebo. Otherwise, there was no significant difference between in adults in the treatment group and placebo group. As an important caveat, the interpretation of safety of nonstandard INCS is restricted to delivery methods and dosages published in the literature.

Keywords: adverse effect; complication; corticosteroid; intranasal steroid; nasal steroid; side effect; topical steroid; toxicity.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • Administration, Intranasal
  • Adrenal Cortex Hormones / administration & dosage*
  • Adrenal Cortex Hormones / adverse effects*
  • Adult
  • Humans
  • Iatrogenic Disease
  • Nasal Sprays*
  • United States
  • United States Food and Drug Administration

Substances

  • Adrenal Cortex Hormones
  • Nasal Sprays