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

Published online by Cambridge University Press:  02 September 2019

Michael E. Yarrington
Affiliation:
Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina
Deverick J. Anderson
Affiliation:
Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina
Elizabeth Dodds Ashley
Affiliation:
Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina
Travis Jones
Affiliation:
Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina
Angelina Davis
Affiliation:
Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina
Melissa Johnson
Affiliation:
Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina
Yuliya Lokhnygina
Affiliation:
Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina
Daniel J. Sexton
Affiliation:
Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina
Rebekah W. Moehring
Affiliation:
Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina
Corresponding

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.

Type
Concise Communication
Copyright
© 2019 by The Society for Healthcare Epidemiology of America. All rights reserved. 

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References

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.Google ScholarPubMed
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.CrossRefGoogle ScholarPubMed
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.Google Scholar
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.Google Scholar
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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.CrossRefGoogle ScholarPubMed

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