Assessing National Trends and Perceived Safety of Off-Label Ciprofloxacin-Dexamethasone Use by Pediatric Otolaryngologists.

OBJECTIVES: Off-label use of Ciprodex® (ciprofloxacin-dexamethasone: CPD), an antibiotic-steroid combination solution, in the airway has been reported by pediatric otolaryngologists with anecdotal success. We examined national trends regarding off-label CPD use including prevalence, common indications, prescriber patterns, adverse events, and accessibility. METHODS: 15-item cross-sectional survey was distributed to American Society of Pediatric Otolaryngology members from January-April 2022. Univariate analyses were performed to compare responses for users of off-label CPD versus non-users. Ease of access was compared across geographies and practice types using multivariate logistic regressions. RESULTS: Of the 163 complete responses (26.6% response rate), 156 (95.7%) reported using off-label CPD. Most common indications for off-label CPD were tracheal granulation (87.8%, n = 137) and choanal atresia (82.1%, n = 128). Ease of access was significantly increased in the Midwest (OR:18.79, 95%CI:3.63-1.24, p = 0.001) and West (OR:29.92, 95%CI:3.55-682.00, p = 0.006). Ease of access was significantly lower at tertiary referral centers (OR:0.11, 95%CI:0.01-0.64, p = 0.041) and private practices (OR:0.04, 95%CI:0.002-0.33, p = 0.009) compared to academic free-standing children's hospitals. Two-thirds of respondents reported feeling "Very Comfortable" with the safety profile of off-label CPD; 99.4% (n = 156) felt that the benefits outweighed the risks of off-label use. Seven respondents (4.5%) reported adverse events (e.g., local allergic reaction, cushingoid symptoms) from off-label use. CONCLUSIONS: Our findings (26.6% response rate) suggest that off-label CPD is commonly used by pediatric otolaryngologists, many of whom reported feeling that the benefits of off-label CPD outweigh the risks. Our results establish a baseline for future efforts to assess the efficacy and safety of off-label CPD and to improve its accessibility. LEVEL OF EVIDENCE: V Laryngoscope, 134:2922-2930, 2024.

Off-Label Use of Ciprofloxacin/Dexamethasone Drops in the Pediatric Upper Airway: Case Presentation and Review of Adverse Effects.

OBJECTIVE: This report describes a new observation of hyperglycemia in a child with Type 1 diabetes after off-label use of otic ciprofloxacin/dexamethasone drops in the nasal passage and reviews previous reports of adverse endocrine effects from intranasal corticosteroids in pediatric patients. METHODS: We describe the clinical case and conducted a literature review of MEDLINE (PubMed) and EMBASE. RESULTS: A 9-month-old female with a history of Type 1 diabetes who underwent unilateral choanal atresia repair was started on 1 week of ciprofloxacin 0.3%/dexamethasone 0.1% otic drops twice a day for choanal obstruction with granulation tissue. While the patient's airway patency improved, average daily blood glucose increases by 40 to 50 points were noted on the patient's continuous glucose monitor. The hyperglycemia resolved within 2 days after switching to mometasone furoate 0.05% spray. We also review 21 pediatric otolaryngology cases of iatrogenic Cushing's syndrome associated with on- and off-label use of topical steroid suspensions in the airway. Patients ranged from 3 months to 16 years in age and used doses of 50 µg/day to 2 mg/day. CONCLUSION: This is the first reported pediatric case of increased blood glucose levels associated with intranasal steroid suspensions, to the best of our knowledge. Counseling families on precise dose administration and potential endocrine disturbances is critical when prescribing these medications for off-label use in infants and small children, particularly among patients with underlying endocrine disorders such as diabetes.