Evaluation of FDA Boxed Warning on Prescribing Patterns of Fluoroquinolones for Uncomplicated Urinary Tract Infections

Ann Pharmacother. 2019 Dec;53(12):1192-1199. doi: 10.1177/1060028019865224. Epub 2019 Jul 18.


Background: Little is known regarding the impact of the Food and Drug Administration (FDA) boxed warning on prescribing rates of fluoroquinolone (FQ) antibiotics in the outpatient setting. Objective: The primary objective of this study was to evaluate the 2016 FDA boxed warning update on FQ prescribing rates for uncomplicated urinary tract infection (uUTI). Methods: This was a single-center retrospective cohort study conducted at 6 family medicine practices, including women aged 18 to 65 years with an outpatient visit for uUTI from January 1, 2016, to December 31, 2016. Results: A total of 436 patients met inclusion. FQs were prescribed in 38% of patients before the FDA boxed warning and in 30% of patients after (8% reduction). Non-FQ prescribing had a corresponding 8% increase, comprising 62% of uUTI prescribing before the FDA boxed warning and 70% after (P = 0.08). The likelihood of being prescribed a FQ was not significantly different following release of the FDA boxed warning (adjusted odds ratio = 0.67 [95% CI = 0.41-1.10]). Variables significantly associated with an increase in FQ prescribing based on logistic regression were age ≥58 years and chronic kidney disease. Concordance of antibiotic prescribing with the Infectious Diseases Society of America clinical practice guidelines for uUTI was low, and the incidence of treatment failure was low. Conclusion and Relevance: The 2016 FDA boxed warning was not significantly associated with decreased FQ prescribing for uUTI across a large academic family medicine practice. Methods to improve education and disseminate FDA warnings in practice are needed.

Keywords: ambulatory care; antibiotics; family medicine; fluoroquinolone; prescribing patterns; urinary tract infection.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Drug Labeling / standards*
  • Drug Prescriptions / standards
  • Drug Prescriptions / statistics & numerical data*
  • Female
  • Fluoroquinolones / administration & dosage
  • Fluoroquinolones / adverse effects
  • Fluoroquinolones / therapeutic use*
  • Humans
  • Logistic Models
  • Male
  • Middle Aged
  • Outpatients
  • Practice Patterns, Physicians' / standards
  • Practice Patterns, Physicians' / statistics & numerical data*
  • Retrospective Studies
  • United States
  • United States Food and Drug Administration
  • Urinary Tract Infections / drug therapy*
  • Urinary Tract Infections / epidemiology
  • Young Adult


  • Anti-Bacterial Agents
  • Fluoroquinolones