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Antibiotic Use in Hospital Urinary Tract Infections After FDA Regulation.

Aaron Brant1, Patrick Lewicki2, Xian Wu2

  • 1Department of Urology, New York-Presbyterian Hospital, Weill Cornell Medical College, New York, NY, USA. aab9038@med.cornell.edu.

Journal of General Internal Medicine
|December 26, 2023
PubMed
Summary
This summary is machine-generated.

FDA "black box" warnings led to decreased fluoroquinolone use for urinary tract infections (UTIs). This shift corresponded with reduced fluoroquinolone resistance and increased ceftriaxone prescriptions.

Keywords:
antibioticsgovernment regulationurinary tract infection

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Area of Science:

  • Infectious Diseases
  • Pharmacovigilance
  • Antimicrobial Stewardship

Background:

  • The U.S. Food and Drug Administration (FDA) issued a "black box" warning on fluoroquinolone risks in 2008, with subsequent updates in 2011, 2013, and 2016.
  • These warnings highlighted significant safety concerns associated with fluoroquinolone antibiotic use.

Purpose of the Study:

  • To analyze trends in antimicrobial prescribing for hospital-treated urinary tract infections (UTIs) between 2000 and 2020.
  • To evaluate the impact of FDA "black box" warnings on fluoroquinolone utilization and resistance patterns.

Main Methods:

  • A cross-sectional study utilizing interrupted time series analysis was conducted.
  • Data included nearly 10 million patient encounters with a UTI diagnosis from January 2000 to March 2020.
  • Monthly antibiotic use (fluoroquinolone and non-fluoroquinolone) and fluoroquinolone resistance in available cultures were assessed.

Main Results:

  • Fluoroquinolone use for UTIs decreased significantly from 61.7% in July 2008 to 11.7% in March 2020.
  • Concurrently, ceftriaxone use increased from 26.4% to 63.6% during the same period.
  • Fluoroquinolone resistance declined by 28.9% (2009-2020), and the 2008 FDA warning was linked to a significant decrease in fluoroquinolone use.

Conclusions:

  • FDA "black box" warnings were associated with a substantial reduction in fluoroquinolone prescribing for UTIs.
  • This decrease correlated with a decline in fluoroquinolone resistance and a rise in the use of alternative antibiotics like ceftriaxone.
  • Restrictions on one antibiotic class may lead to increased reliance on alternatives, potentially altering resistance dynamics.