The US Food and Drug Administration (FDA) removed systematic quinolones’ indications for various diseases amid the concerns of risks outweighing benefits. However, how the change influenced the use of oral quinolone is not known. This study aims to investigate the association of oral quinolone safety warnings and indication restrictions with use.
This interrupted time series analysis evaluated the monthly prevalence of oral quinolone-treated infection episodes using a national sample of privately insured patients in outpatient care. Time before and after FDA mandated label changes was considered. The primary endpoint of the study was monthly oral quinolone use prevalence before and after label changes.
Before the label change, quinolone prevalence among antibiotic-treated uUTI episodes was 41.6%. Similarly, it was 8.3% for AS and 31.9% for AE-COPD. The trends in monthly quinolone prevalence were nearly flat before the label changes. Immediate reductions in prevalence were noted in the month of label changes, and since then, they have gradually plummeted. Since then, the treatment has shifted to front-line and other second-line agents; however, the use of non-recommended antibiotics also increased.
The research concluded that label changes were associated with an immediate reduction in the prevalence of quinolone use for uUTIs, AS, and AE-COPD.