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Risk of retinal detachment and exposure to fluoroquinolones, common antibiotics, and febrile illness using a self-controlled case series study design: Retrospective analyses of three large healthcare databases in the US.
Londhe, Ajit A; Holy, Chantal E; Weaver, James; Fonseca, Sergio; Villasis-Keever, Angelina; Fife, Daniel.
Affiliation
  • Londhe AA; Janssen Pharmaceutical Research & Development, LLC, Titusville, NJ, United States of America.
  • Holy CE; Johnson & Johnson, New Brunswick, NJ, United States of America.
  • Weaver J; Janssen Pharmaceutical Research & Development, LLC, Titusville, NJ, United States of America.
  • Fonseca S; Janssen Pharmaceutical Research & Development, LLC, Titusville, NJ, United States of America.
  • Villasis-Keever A; Janssen Pharmaceutical Research & Development, LLC, Titusville, NJ, United States of America.
  • Fife D; Janssen Pharmaceutical Research & Development, LLC, Titusville, NJ, United States of America.
PLoS One ; 17(10): e0275796, 2022.
Article in En | MEDLINE | ID: mdl-36201545
OBJECTIVE: The risk of retinal detachment (RD) following exposure to fluoroquinolone (FQ) has been assessed in multiple studies, however, results have been mixed. This study was designed to estimate the risk of RD following exposure to FQ, other common antibiotics, and febrile illness not treated with antibiotics (FINTA) using a self-controlled case series (SCCS) study design to reduce risk of confounding from unreported patient characteristics. DESIGN: Retrospective database analysis-SCCS. SETTING: Primary and Secondary Care. STUDY POPULATION: 40,981 patients across 3 US claims databases (IBM® MarketScan® commercial and Medicare databases, Optum Clinformatics). OUTCOME: RD. METHODS: Exposures included FQ as a class of drugs, amoxicillin, azithromycin, trimethoprim with and without sulfamethoxazole, and FINTA. For the primary analysis, all drug formulations were included. For the post hoc sensitivity analyses, only oral tablets were included. Risk windows were defined as exposure period (or FINTA duration) plus 30 days. Patients of all ages with RD and exposures in 3 US claims databases between 2012 to 2017 were included. Diagnostics included p value calibration and pre-exposure outcome analyses. Incidence rate ratios (IRR) and 95% confidence interval (CI) comparing risk window time with other time were calculated. RESULTS: Our primary analysis showed an increased risk for RD in the 30 days prior to exposure to FQ or trimethoprim without sulfamethoxazole. This risk decreased but remained elevated for 30 days following first exposure. Our post-hoc analysis, which excluded ophthalmic drops, showed no increased risk for RD at any time, with FQ and other antibiotics. CONCLUSION: Our results did not suggest an association between FQ and RD. Oral FQ was not associated with an increased risk for RD during the pre- or post-exposure period. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03479736-March 21, 2018.
Subject(s)

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Retinal Detachment / Fluoroquinolones Type of study: Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Aged / Humans Country/Region as subject: America do norte Language: En Journal: PLoS One Journal subject: CIENCIA / MEDICINA Year: 2022 Document type: Article Affiliation country: United States Country of publication: United States

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Retinal Detachment / Fluoroquinolones Type of study: Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Aged / Humans Country/Region as subject: America do norte Language: En Journal: PLoS One Journal subject: CIENCIA / MEDICINA Year: 2022 Document type: Article Affiliation country: United States Country of publication: United States