Abstract | Importance: Objective: To assess the association of oral quinolone safety warnings and indication restrictions with use. Design, Setting, and Participants: This interrupted time series (January 2015-November 2018) analysis of the monthly prevalence of oral quinolone-treated infection episodes used a national sample of privately insured patients in outpatient care from the IBM MarketScan Database and included adults with antibiotic treatment of new uUTI, AS, or AE- COPD episodes, excluding patients with conditions that complicate infections, previous hospitalization, or other infections. Exposures: Time before and after May 2016 when the FDA mandated label changes. Main Outcomes and Measures: Monthly oral quinolone use prevalence by each condition before and after the label changes, overall and stratified by prescriber specialty. Results: In January 2015, quinolone prevalence among antibiotic-treated uUTI episodes (n = 652 235) was 41.6% (95% CI, 40.6%-42.5%); AS (n = 1 742 248) was 8.3% (95% CI, 7.9%-8.6%), and AE- COPD (n = 22 817) was 31.9% (95% CI, 30.3%-33.4%). Before the label changes, trends in monthly quinolone prevalence were nearly flat. The month of the label changes we noted an immediate reduction for uUTI (-7.2%; 95% CI, -8.6% to -5.8%); and to a lesser extent for AS (-1.2%; 95% CI, -1.5% to -0.9%) and AE- COPD (-2.6%; 95% CI, -4.1% to -1.1%), and continued monthly declines thereafter. Falsification tests confirmed an immediate decrease after the label change of quinolone use for uUTI but more obscured effects for AS and AE- COPD. Treatment shifted mostly to first-line (eg, nitrofurantoin in uUTI, amoxicillin in AS, macrolides in AE- COPD) and other second-line agents but use of not recommended antibiotics also increased (eg, tetracyclines in AE- COPD). Prescribing preferences varied, but significant reductions were seen across all prescriber specialties. At the end of the study period, quinolone was used for 19.2% of treated uUTIs, 2.9% of treated AS, and 14.6% of treated AE- COPD episodes. Conclusions and Relevance: Label changes and their announcements was associated with an immediate reduction in oral quinolone use for uUTI and to a lesser extent for AS and AE- COPD. Quinolones continued to contribute a considerable proportion of treatments for uUTI and AE- COPD episodes at the end of the study period, pointing to opportunities for further improvement.
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Authors | Phuong T Tran, Patrick J Antonelli, Juan M Hincapie-Castillo, Almut G Winterstein |
Journal | JAMA internal medicine
(JAMA Intern Med)
Vol. 181
Issue 6
Pg. 808-816
(06 01 2021)
ISSN: 2168-6114 [Electronic] United States |
PMID | 33871571
(Publication Type: Journal Article)
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Chemical References |
- Anti-Bacterial Agents
- Quinolones
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Topics |
- Anti-Bacterial Agents
(adverse effects, therapeutic use)
- Drug Prescriptions
- Humans
- Interrupted Time Series Analysis
- Practice Patterns, Physicians'
(trends)
- Pulmonary Disease, Chronic Obstructive
(drug therapy)
- Quinolones
(adverse effects)
- Sinusitis
(drug therapy)
- United States
- United States Food and Drug Administration
- Urinary Tract Infections
(drug therapy)
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