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Pharmacoepidemiol Drug Saf. 2016 Sep;25(9):1042-51. doi: 10.1002/pds.4021. Epub 2016 May 2.

Off-label use of oral fluoroquinolone antibiotics in outpatient settings in the United States, 2006 to 2012.

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James L. Winkle College of Pharmacy, Academic Health Center, University of Cincinnati, Cincinnati, OH, USA.



The aim of this study was to evaluate the practice pattern of off-label use of fluoroquinolones (FQs) in ambulatory settings and to identify the related risk factors.


The National Ambulatory Medical Care Surveys from 2006 through 2012 was used to identify subjects who received FQ off-label prescriptions. We defined off-label use as the use of FQs for indications other than those in the FDA-approved drug label. Descriptive statistics were calculated by using a series of weighted chi-squared statistics. Multivariate logistic regression was conducted to identify factors associated with off-label FQ drug use.


There were 93 million ambulatory visits in which an FQ was prescribed, and 53.16% of these visits involved the prescribing of FQs in an off-label manner. The percentage of off-label prescriptions was the highest among individuals ≥80 years old (61.6%) and male patients (60.9%). The FQ drug prescribed most for an off-label indication in our study was ciprofloxacin (29.5% of the total visits). The multivariate analysis showed that age of ≥80 years and male patient was significantly associated with off-label use of FQs (adjusted odds ratio (OR) 3.66, 1.72-7.80 and OR 3.26, 2.32-4.56, respectively). Medicaid or private insurance versus Medicare were associated with significantly higher off-label prescribing of FQs (OR 2.53, 1.28-5.01 and 1.77, 1.03-3.03, respectively).


The percentage of visits involving off-label FQs in US ambulatory settings is substantial. Efforts are needed consolidate and evaluate what high-quality scientific evidence is available and what is needed to support the safety and effectiveness of such off-label uses. Copyright © 2016 John Wiley & Sons, Ltd.


antibiotics; fluoroquinolones; off-label use; pharmacoepidemiology; prescribing

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