Siddhi Pramod Umarje1,2, Caleb G Alexander1,2,3, Andrew J Cohen4. 1. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA. 2. Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA. 3. Division of General Internal Medicine, Johns Hopkins Medicine, Baltimore, Maryland, USA. 4. The Brady Urological Institute at Johns Hopkins Bayview Medical Center, Baltimore, Maryland, USA.
Abstract
BACKGROUND: Frequently used fluoroquinolones have been subject to increasing safety concerns and regulatory alerts. This study characterized ambulatory fluoroquinolone utilization in the United States and evaluated the impact of 2016 Food and Drug Administration (FDA) safety advisories on its use. METHODS: We used IQVIA's National Disease and Therapeutic Index to quantify adult outpatient fluoroquinolone use ("treatment visits"). Descriptive statistics and segmented regression were used to report trends and quantify the varied use before and after FDA's 2016 alerts. RESULTS: Between 2015 to 2019, fluoroquinolone use decreased by 26.7% (18.7 million treatment visits in 2015 to 13.7 million treatment visits in 2019). Annual use declined by 44%, 24%, and 24% for respiratory, urogenital, and gastrointestinal conditions, respectively; and by 66% among providers ≤44 years old vs negligible decline among those ≥65 years old. Before 2016 FDA advisories, there were approximately 4.8 million fluoroquinolone treatment visits/quarter, which had a statistically significant immediate drop by 641035 visits (95% confidence interval [CI], -937368 to -344702; P=.000) after FDA's 2016 advisories. A statistically significant difference of approximately 45000 visits/quarter (95% CI, -85956 to -3122; P=.036) was observed after the advisories. CONCLUSIONS: Large reductions in ambulatory fluoroquinolone use in the United States have coincided with increasing evidence of safety concerns and FDA advisories. However, fluoroquinolone use varies significantly based on patient and provider characteristics, suggesting heterogeneous effects of emerging risks on clinical practice. Published by Oxford University Press on behalf of Infectious Diseases Society of America 2021.
BACKGROUND: Frequently used fluoroquinolones have been subject to increasing safety concerns and regulatory alerts. This study characterized ambulatory fluoroquinolone utilization in the United States and evaluated the impact of 2016 Food and Drug Administration (FDA) safety advisories on its use. METHODS: We used IQVIA's National Disease and Therapeutic Index to quantify adult outpatient fluoroquinolone use ("treatment visits"). Descriptive statistics and segmented regression were used to report trends and quantify the varied use before and after FDA's 2016 alerts. RESULTS: Between 2015 to 2019, fluoroquinolone use decreased by 26.7% (18.7 million treatment visits in 2015 to 13.7 million treatment visits in 2019). Annual use declined by 44%, 24%, and 24% for respiratory, urogenital, and gastrointestinal conditions, respectively; and by 66% among providers ≤44 years old vs negligible decline among those ≥65 years old. Before 2016 FDA advisories, there were approximately 4.8 million fluoroquinolone treatment visits/quarter, which had a statistically significant immediate drop by 641035 visits (95% confidence interval [CI], -937368 to -344702; P=.000) after FDA's 2016 advisories. A statistically significant difference of approximately 45000 visits/quarter (95% CI, -85956 to -3122; P=.036) was observed after the advisories. CONCLUSIONS: Large reductions in ambulatory fluoroquinolone use in the United States have coincided with increasing evidence of safety concerns and FDA advisories. However, fluoroquinolone use varies significantly based on patient and provider characteristics, suggesting heterogeneous effects of emerging risks on clinical practice. Published by Oxford University Press on behalf of Infectious Diseases Society of America 2021.
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