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Impact of FDA black box warning on fluoroquinolone and alternative antibiotic use in southeastern US hospitals

  • Michael E. Yarrington (a1), Deverick J. Anderson (a1), Elizabeth Dodds Ashley (a1), Travis Jones (a1), Angelina Davis (a1), Melissa Johnson (a1), Yuliya Lokhnygina (a2), Daniel J. Sexton (a1) and Rebekah W. Moehring (a1)...

Abstract

We analyzed antibiotic use data from 29 southeastern US hospitals over a 5-year period to determine changes in antibiotic use after the fluoroquinolone US Food and Drug Administration (FDA) advisory update in 2016. Fluoroquinolone use declined both before and after the FDA announcement, and the use of select, alternative antibiotics increased after the announcement.

Fluoroquinolones are among the 4 most commonly prescribed antibiotic classes.1,2 Postmarketing reports of serious adverse events linked to fluoroquinolones include tendonitis, neuropathy, hypoglycemia, psychiatric side effects, and possible aortic vessel rupture, leading to safety label changes in July 2008 and August 2013.3 In July 2016, the US Food and Drug Administration (FDA) strengthened the “black box” warning following an initial safety announcement in May 2016, recommending avoidance of fluoroquinolones for uncomplicated infections such as acute exacerbation of chronic bronchitis, uncomplicated urinary tract infections, and acute bacterial sinusitis.4 Concerns over safety and the association with Clostridiodes difficile infection have led inpatient antimicrobial stewardship programs (ASPs) to develop initiatives to promote avoidance of quinolones. The objective of this study was to quantify the effect of the 2016 FDA “black box” update on inpatient antibiotic use among a cohort of southeastern US hospitals.

Copyright

Corresponding author

Author for correspondence: Michael E. Yarrington, MD, Email: michael.yarrington@duke.edu.

References

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1. Hicks, LA, Bartoces, MG, Roberts, RM, et al. US outpatient antibiotic prescribing variation according to geography, patient population, and provider specialty in 2011. Clin Infect Dis 2015;60:13081316.
2. Baggs, J, Fridkin, SK, Pollack, LA, Srinivasan, A, Jernigan, JA. Estimating national trends in inpatient antibiotic use among us hospitals from 2006 to 2012. JAMA Intern Med 2016;176:16391648.
3. FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients. Food and Drug Administration website. https://www.fda.gov/Drugs/DrugSafety/ucm628753.htm. Published 2018. Accessed December 26, 2018.
4. FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects. Food and Drug Administration website. https://www.fda.gov/downloads/Drugs/DrugSafety/UCM513019.pdf. Published 2016. Accessed July 17, 2018.
5. Hawkins, MR, Drew, RH, Lewis, SS, Anderson, DJ, Sexton, DJ, Moehring, RW. Characteristics of antimicrobial stewardship activities in community hospitals upon enrollment in the Duke Antimicrobial Stewardship Outreach Network (DASON). Open Forum Infect Dis 2014;1:S96.
6. Almalki, ZS, Yue, X, Xia, Y, Wigle, PR, Guo, JJ. Utilization, spending, and price trends for quinolones in the US Medicaid programs: 25 years’ experience, 1991–2015. PharmacoEcon Open 2017;1:123131.
7. Kelly, AA, Jones, MM, Echevarria, KL, et al. A report of the efforts of the Veterans’ Health Administration National Antimicrobial Stewardship Initiative. Infect Control Hosp Epidemiol 2017;38:513520.
8. Dalhoff, A. Global fluoroquinolone resistance epidemiology and implictions for clinical use. Interdiscip Perspect Infect Dis 2012;2012:976273.
9. Pépin, J, Saheb, N, Coulombe, M-A, et al. Emergence of fluoroquinolones as the predominant risk factor for Clostridium difficile–associated diarrhea: a cohort study during an epidemic in Quebec. Clin Infect Dis 2005;41:12541260.
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Impact of FDA black box warning on fluoroquinolone and alternative antibiotic use in southeastern US hospitals

  • Michael E. Yarrington (a1), Deverick J. Anderson (a1), Elizabeth Dodds Ashley (a1), Travis Jones (a1), Angelina Davis (a1), Melissa Johnson (a1), Yuliya Lokhnygina (a2), Daniel J. Sexton (a1) and Rebekah W. Moehring (a1)...

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