Appropriateness of Otic Quinolone Use among Privately Insured US Patients

Tran, Phuong; Winterstein, Almut G.; Xi, Wang; Rhew, Kiyon; Antonelli, Patrick J.

doi:10.1177/0194599819889607

Cited by 2 publications

(1 citation statement)

References 31 publications

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“…We also conducted stratified analyses by prescriber specialty obtained from the index outpatient encounter . We assumed the clinician who diagnosed the index indications was the same person who prescribed antibiotics.…”

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confidence: 88%

Association of US Food and Drug Administration Removal of Indications for Use of Oral Quinolones With Prescribing Trends

et al. 2021

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IMPORTANCEIn May 2016, due to concerns of the risks outweighing the benefits, the US Food and Drug Administration (FDA) removed systemic quinolones' indications for acute, uncomplicated urinary tract infection (uUTI), acute sinusitis (AS), and acute exacerbation of chronic obstructive pulmonary disease (AE-COPD). How the change influenced oral quinolone use is unknown.OBJECTIVE To assess the association of oral quinolone safety warnings and indication restrictions with use. DESIGN, SETTING, AND PARTICIPANTSThis 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 MEASURESMonthly oral quinolone use prevalence by each condition before and after the label changes, overall and stratified by prescriber specialty. RESULTSIn 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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Section: Methodssupporting

confidence: 88%

Association of US Food and Drug Administration Removal of Indications for Use of Oral Quinolones With Prescribing Trends

et al. 2021

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Quinolone Ear Drops and Achilles Tendon Rupture

Tran

Antonelli

Winterstein

2022

Clinical Infectious Diseases

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Background Delayed eardrum healing has been observed in the ear opposite to the ear treated with otic quinolones (OQ) in rats. Case reports describe tendinopathies after OQ treatment, suggesting adverse systemic effects. Methods We studied patients 19-64 years with diagnosis of otitis externa or media in private insurance between 2005-2015. We compared OQ treatment against otic neomycin, oral amoxicillin or azithromycin. Outcomes included Achilles tendon rupture (ATR), Achilles tendinitis (AT) and all-type tendon rupture (ATTR). We applied an active comparator, new user design with 1-year look-back and ceased follow-up at initiation of systemic steroids or oral quinolones, external injury, hospitalization and after 35 days. We used trimmed stabilized inverse probability of treatment weights to balance comparison groups in a survival framework. Negative outcomes (clavicle fractures or sports injuries) were examined to rule out differences due to varied physical activity (unmeasured confounding). Results We examined 1,501,009 treated otitis episodes. Hazard ratios (HR) for OQ exposure associated with ATR were 4.49 (95%CI 1.83-11.02), AT 1.04 (95%CI 0.73-1.50), ATTR 1.71 (95%CI 1.21-2.41). Weighted risk differences (RD) per 100,000 episodes for OQ exposure were ATR 7.80 (95%CI 0.72-14.89), AT 1.01 (95%CI –12.80-14.81), ATTR 18.57 (95%CI 3.60-33.53). Corresponding HRs and RDs for clavicle fractures and sports injuries were HR = 1.71 (95%CI 0.55-5.27) and HR = 1.45 (95%CI 0.64-3.30), suggesting limited residual confounding. Conclusions OQ exposure may lead to systemic consequences. Clinicians should consider this potential risk and counsel patients accordingly. Risk factors and mechanisms for this rare, adverse effect deserve further evaluation. Mechanistic and other clinical studies are warranted to corroborate this finding. Presented at the American Otological Society 154th Annual Virtual Meeting; April 11, 2021

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Appropriateness of Otic Quinolone Use among Privately Insured US Patients

Cited by 2 publications

References 31 publications

Association of US Food and Drug Administration Removal of Indications for Use of Oral Quinolones With Prescribing Trends

Association of US Food and Drug Administration Removal of Indications for Use of Oral Quinolones With Prescribing Trends

Quinolone Ear Drops and Achilles Tendon Rupture

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