From Routine to Restricted: Impact of the FDA Black Box Warning on Fluoroquinolones on the Treatment of Simple Cystitis in Women
Document Type
Conference Proceeding
Publication Date
5-2026
Publication Title
Journal of Urology
Abstract
INTRODUCTION AND OBJECTIVES: Fluoroquinolones (FQs)are no longer recommended as first-line therapy for uncomplicated cystitis due to increased side-effect risk and rising antimicrobial resistance. Despite guideline changes, their use remains common. We evaluated prescribing patterns for uncomplicated urinary tract infection (UTI) in women across a large midwestern health system with a focus on specialty-specific trends before and after the FDA Drug Safety Communication from July 2016.METHODS: We performed a retrospective chart review using EPIC within a single, multi-site health system. Female patients diagnosed with simple cystitis were identified from January2012eDecember 2024. Antibiotic prescriptions were analyzed to determine specific antibiotics used, the proportion of FQs prescribed, and specialty-specific prescribing patterns. Based on the FDA black box warning, we split our analysis into two time periods: January2012-July 2016 and August 2016-December 2024.RESULTS: A total of 21,656 antibiotic prescriptions were identified from 2012-2024, of which 4,359 were FQs (20.1%). Antibiotics for simple cystitis were most often prescribed by emergency medicine(EM) providers (67.8%), internal medicine (IM) providers (22.8%), and family medicine (FM) providers (5.7%). Prior to the FDA warning, FQs were the most prescribed antibiotic class for simple cystitis (55.0%)followed by cephalosporins (19.6%) and nitrofurantoin (17.9%). After the FDA warning, the most prescribed antibiotics were cephalosporins(50.2%) followed by nitrofurantoin (19.4%) and FQs (16.6%). FQs were most often prescribed by EM providers (40.9%) followed by IM (39.3%)and FM (5.7%). Following the FDA warning, FQ use for uncomplicated UTIs dropped from 41.5% to 11.3% among EM providers, from 64.0% to30.4% among IM providers, and from 62.0% to 16.6% among FM providers. Urology providers were responsible for 0.5% of all antibiotics prescribed for simple cystitis; 54.6% of these prescriptions were FQs prior to the FDA warning compared to 34.0% after. CONCLUSIONS: Updated treatment guidelines have caused a shift in prescribing patterns to favor cephalosporin use in uncomplicated UTI over FQs. However, FQs continue to be prescribed at high rates, with substantial variation by specialty. Although urology providers contributed a small proportion of antibiotic prescriptions for simple cystitis, they prescribe a relatively high proportion of FQs. This underscores the need for enhanced antimicrobial stewardship and CME to reduce inappropriate FQ use in uncomplicated UTI.
Volume
215
Issue
5S
First Page
e961
Last Page
e961
Recommended Citation
Kennedy AJ, Zwaans BMM, Padmanabhan P. From routine to restricted: impact of the FDA black box warning on fluoroquinolones on the treatment of simple cystitis in women. J Urol. 2026 May;215(5S):e961. doi:10.1097/01.JU.0001191560.88204.f7.09 and Kennedy A, Zwaans B, Padmanabhan P. From routine to restricted: impact of the FDA black box warning on fluoroquinolones on the treatment of simple cystitis. Mich Med Educ Health Bull. 2026 Jun 29;4(2 suppl). doi:10.69735/001c.163884. Available from:https://mmehb.scholasticahq.com/article/163884-from-routine-to-restricted-impact-of-the-fda-black-box-warning-on-fluoroquinolones-on-the-treatment-of-simple-cystitis
DOI
10.1097/01.JU.0001191560.88204.f7.09
Comments
American Urological Association Annual Meeting, May 15-18, 2026, Washington, DC and 48th Annual SEMCME (Southeast Michigan Center for Medical Education) Research Forum, May 20, 2026, Troy, MI