FDA Lends an Outpatient Stewardship Hand

Reviewed by Cynthia T. Nguyen, PharmD, University of Chicago Medicine 

Between 2015 through 2019, fluoroquinolone fills in the United States decreased 10.8% annually (p=0.001), with a significant reduction associated with the release of the first Food and Drug Administration (FDA) warning (advising limiting use among patients with acute sinusitis, acute bronchitis, and uncomplicated UTIs). In this database study, Buehrle and colleagues evaluated annual and monthly fills between 3 time periods: baseline (August 2014–April 2016), first FDA warning period (May 2016–June 2018), and second FDA warning period (July 2018–February 2020). During the baseline period, no changes in monthly fills were observed. In the month after the release of the first FDA warning and throughout the first and second FDA warning periods, monthly fills decreased. In comparison, there were no significant changes in amoxicillin fills throughout the study period. Though increased focus on outpatient antimicrobial stewardship may have also influenced prescribing, the temporal reduction in fluoroquinolone fills suggests that FDA safety warnings have an impact on prescribing practices and can be leveraged as tools for antimicrobial stewardship.


Buehrle DJ, Wagener MM, Clancy CJ. Outpatient Fluoroquinolone Prescription Fills in the United States, 2014-2020: Assessing the Impact of Food and Drug Administration Safety Warnings. Antimicrob Agents Chemother. 2021 Apr 19:AAC.00151-21

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