Risk for Tympanic Membrane Perforation After Quinolone Ear Drops for Acute Otitis Externa.


Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213

Informations de publication

Date de publication:
03 03 2020
Historique:
received: 13 11 2018
accepted: 24 04 2019
pubmed: 3 5 2019
medline: 7 1 2021
entrez: 3 5 2019
Statut: ppublish

Résumé

This study examined whether the use of quinolone ear drops increased the risk of perforation with intact tympanic membranes and acute otitis externa (AOE). This was a retrospective cohort study using Medicaid clinical encounter and pharmacy billing records from 1999 through 2010. Children and adults had to have 24 months continuous enrollment in Medicaid prior to the first antibiotic ear drop dispensing (index date), and they had to maintain their enrollment for at least 18 months thereafter. Included ear drops were ofloxacin, ciprofloxacin plus hydrocortisone, ciprofloxacin plus dexamethasone, and neomycin plus hydrocortisone. Tympanic membrane perforation (TMP) was identified as 2 inpatient or outpatient encounters associated with TMP diagnosis at least 30 days apart. A Cox regression model adjusting for patient demographics, calendar year, and the number of ear drop prescriptions was used to compare TMP risk between quinolone and neomycin-exposed patients. A total of 94 333 patients entered the study cohort. Use of quinolone ear drops was associated with increased risk for TMP compared with neomycin plus hydrocortisone, with an adjusted hazard ratio of 2.26 (95% confidence interval [CI], 1.34-3.83). Adjusted hazard ratios were 2.53 (95% CI, 1.27-5.05) for ofloxacin, 2.24 (95% CI, 1.03-4.85) for ciprofloxacin plus hydrocortisone, and 2.30 (95% CI, 1.09-4.87) for ciprofloxacin plus dexamethasone. Sensitivity analyses were consistent with the primary analysis. Use of quinolone ear drops to treat AOE is associated with a previously unreported increased risk of developing TMPs. Selection of otic preparations to treat self-limited conditions with intact tympanic membranes should consider TMP risk.

Sections du résumé

BACKGROUND
This study examined whether the use of quinolone ear drops increased the risk of perforation with intact tympanic membranes and acute otitis externa (AOE).
METHODS
This was a retrospective cohort study using Medicaid clinical encounter and pharmacy billing records from 1999 through 2010. Children and adults had to have 24 months continuous enrollment in Medicaid prior to the first antibiotic ear drop dispensing (index date), and they had to maintain their enrollment for at least 18 months thereafter. Included ear drops were ofloxacin, ciprofloxacin plus hydrocortisone, ciprofloxacin plus dexamethasone, and neomycin plus hydrocortisone. Tympanic membrane perforation (TMP) was identified as 2 inpatient or outpatient encounters associated with TMP diagnosis at least 30 days apart. A Cox regression model adjusting for patient demographics, calendar year, and the number of ear drop prescriptions was used to compare TMP risk between quinolone and neomycin-exposed patients.
RESULTS
A total of 94 333 patients entered the study cohort. Use of quinolone ear drops was associated with increased risk for TMP compared with neomycin plus hydrocortisone, with an adjusted hazard ratio of 2.26 (95% confidence interval [CI], 1.34-3.83). Adjusted hazard ratios were 2.53 (95% CI, 1.27-5.05) for ofloxacin, 2.24 (95% CI, 1.03-4.85) for ciprofloxacin plus hydrocortisone, and 2.30 (95% CI, 1.09-4.87) for ciprofloxacin plus dexamethasone. Sensitivity analyses were consistent with the primary analysis.
CONCLUSIONS
Use of quinolone ear drops to treat AOE is associated with a previously unreported increased risk of developing TMPs. Selection of otic preparations to treat self-limited conditions with intact tympanic membranes should consider TMP risk.

Identifiants

pubmed: 31044229
pii: 5482480
doi: 10.1093/cid/ciz345
doi:

Substances chimiques

Anti-Bacterial Agents 0
Quinolones 0
Ofloxacin A4P49JAZ9H

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1103-1109

Informations de copyright

© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Auteurs

Xi Wang (X)

Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, Gainesville.

Almut G Winterstein (AG)

Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, Gainesville.
Department of Epidemiology, College of Public Health and Health Professions, University of Florida, Gainesville.

Adel Alrwisan (A)

Food and Drug Authority, Riyadh, Saudi Arabia.

Patrick J Antonelli (PJ)

Department of Otolaryngology, College of Medicine, University of Florida, Gainesville.

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