Abstract
BackgroundFluoroquinolones are used for conditions including sinusitis, bronchitis, and urinary tract infections. It has been suggested that exposure to fluoroquinolones for these conditions is associated with disability resulting from adverse events in 2 or more organ systems. The objectives were to: describe: 1) fluoroquinolone, azithromycin, and sulfamethoxazole / trimethoprim utilization for these infections; 2) the rate of disability associated with exposure to each of these antibiotic classes and adverse events in 2 or more system organ classes, and 3) compare outcome rates for each of the antibiotic classes.MethodsThis study was conducted using administrative data to mitigate the limitations of spontaneous reports. The sampling frame was a U.S. population with both medical and disability insurance, including patients with the above uncomplicated infections who were prescribed the antibiotics of interest.The primary outcome was an incident short-term disability claim associated with adverse events in 2 different organ systems within 120 days of exposure. A matched analysis was used to compare the outcome for patients receiving each of the drug classes.ResultsAfter propensity score matching, there were 119,653 individuals in each of the exposure groups. There were 264 fluoroquinolone associated disability events and 243 azithromycin/ sulfamethoxazole associated disability events (relative risk =1.09 (95% CI: 0.92–1.30; calibrated p = 0.84)). The results were not significantly different from the null hypothesis of no difference between groups.ConclusionComparative assessments are difficult to conduct in spontaneous reports. This examination of disability associated with adverse events in different system organ classes showed no difference between fluoroquinolones and azithromycin or sulfamethoxazole in administrative data.
Highlights
Fluoroquinolones are used for conditions including sinusitis, bronchitis, and urinary tract infections
The FDA determined that the fluoroquinolones should be reserved for use in patients that have no other options for the following indications: acute sinusitis (AS), acute bacterial exacerbation of chronic obstructive pulmonary disease (AB) and uncomplicated urinary tract infection (UTI)
The primary objectives of this study were to: Describe drug utilization for fluoroquinolone (FQ), azithromycin (AZ) for sinusitis and bronchitis, and sulfamethoxazole / trimethoprim (ST) for urinary tract infection in an entire health claims database and among those individuals in that database who eligible for short term disability benefits
Summary
Fluoroquinolones are used for conditions including sinusitis, bronchitis, and urinary tract infections. The FDA determined that the fluoroquinolones should be reserved for use in patients that have no other options for the following indications: acute sinusitis (AS), acute bacterial exacerbation of chronic obstructive pulmonary disease (AB) and uncomplicated urinary tract infection (UTI). In these indications, the FDA concluded that the risks of these serious side effects generally outweigh the benefits of the use of these antibiotics and all fluoroquinolone labels for systemic use were changed to reflect this recommendation [1]. Practice guidelines and reviews by experts consider FQ as alternative to recommended therapy for the treatment of AS [2,3,4], AB [5–9] and UTI [10, 11]
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