Adel Alrwisan1,2, Patrick J Antonelli3, Almut G Winterstein1,4. 1. Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, USA. 2. Saudi Food and Drug Authority, Riyadh, Saudi Arabia. 3. Department of Otolaryngology-Head and Neck Surgery, University of Florida, Gainesville, Florida, USA. 4. Department of Epidemiology, College of Public Health and Health Professions and College of Medicine, University of Florida, Gainesville, USA.
Abstract
Background: This study investigated whether quinolone ear drops, with or without corticosteroids, increase the risk of perforation requiring tympanoplasty following tympanostomy tube (TT) placement in children. Methods: This was a retrospective cohort study using Medicaid encounter and pharmacy billing data from 29 US states between 1999 and 2006. Children <18 years old without predisposing factors for perforation during a 6-month look-back period entered the cohort after TT placement and first dispensing of antibiotic ear drops. Included ear drops were quinolones (ofloxacin, ciprofloxacin plus hydrocortisone, or ciprofloxacin plus dexamethasone) or neomycin plus hydrocortisone. Children were followed until end of 2006, end of Medicaid enrollment, or occurrence of study outcome. A Cox regression model, adjusted for age, sex, race/ethnicity, initial TT indication, reinsertion of TT, adenoidectomy, and number of ear drop prescriptions was used to compare the rate of perforation between quinolone and neomycin plus hydrocortisone ear drop-exposed children. Perforation was defined by its diagnosis code followed by a tympanoplasty code. Results: A total of 96595 children entered the study cohort. Patients exposed to quinolone ear drops had a higher risk of perforation, with an adjusted hazard ratio of 1.61 (95% confidence interval [CI], 1.15-2.26). The adjusted hazard ratios were 1.49 (95% CI, 1.05-2.09) for ofloxacin, 1.94 (95% CI, 1.32-2.85) for ciprofloxacin plus hydrocortisone, and 2.00 (95% CI, 1.18-3.41) for ciprofloxacin plus dexamethasone. Conclusions: Exposure of children with TT to quinolone ear drops is associated with increased risk of perforations requiring tympanoplasty, which appears to be further exaggerated by corticosteroids. Clinicians should consider the risk of perforation and counsel patients/families accordingly when prescribing quinolone ear drops.
Background: This study investigated whether quinolone ear drops, with or without corticosteroids, increase the risk of perforation requiring tympanoplasty following tympanostomy tube (TT) placement in children. Methods: This was a retrospective cohort study using Medicaid encounter and pharmacy billing data from 29 US states between 1999 and 2006. Children <18 years old without predisposing factors for perforation during a 6-month look-back period entered the cohort after TT placement and first dispensing of antibiotic ear drops. Included ear drops were quinolones (ofloxacin, ciprofloxacin plus hydrocortisone, or ciprofloxacin plus dexamethasone) or neomycin plus hydrocortisone. Children were followed until end of 2006, end of Medicaid enrollment, or occurrence of study outcome. A Cox regression model, adjusted for age, sex, race/ethnicity, initial TT indication, reinsertion of TT, adenoidectomy, and number of ear drop prescriptions was used to compare the rate of perforation between quinolone and neomycin plus hydrocortisone ear drop-exposed children. Perforation was defined by its diagnosis code followed by a tympanoplasty code. Results: A total of 96595 children entered the study cohort. Patients exposed to quinolone ear drops had a higher risk of perforation, with an adjusted hazard ratio of 1.61 (95% confidence interval [CI], 1.15-2.26). The adjusted hazard ratios were 1.49 (95% CI, 1.05-2.09) for ofloxacin, 1.94 (95% CI, 1.32-2.85) for ciprofloxacin plus hydrocortisone, and 2.00 (95% CI, 1.18-3.41) for ciprofloxacin plus dexamethasone. Conclusions: Exposure of children with TT to quinolone ear drops is associated with increased risk of perforations requiring tympanoplasty, which appears to be further exaggerated by corticosteroids. Clinicians should consider the risk of perforation and counsel patients/families accordingly when prescribing quinolone ear drops.