Fluoroquinolones May Double Acute Kidney Injury Risk

Joe Barber Jr, PhD

June 03, 2013

Current fluoroquinolone use may elevate the risk for kidney injury, according to the findings of a population-based retrospective study.

Steven T. Bird, PharmD, from the US Food and Drug Administration in Silver Spring, Maryland, and the University of Florida in Gainesville, and colleagues published their findings online June 3 in the Canadian Medical Association Journal.

"Case reports of acute kidney injury with the use of fluoroquinolones have been published, and the product label includes renal failure in a list of potential, but uncommon, adverse reactions," the authors write. "In clinical practice, when oral fluoroquinolones are prescribed, the potential for acute kidney injury is generally not a clinical consideration."

In the study, the authors assessed the risk for acute kidney injury associated with fluoroquinolones among men aged 40 to 85 years who were enrolled in the US LifeLink Health Plan Claims Database between 2001 and 2011. They identified 1292 men with acute kidney injury and 12,651 matched control participants. Current fluoroquinolone use was linked with a 2.18-fold (95% confidence interval [CI], 1.74 - 2.73) higher risk for acute kidney injury compared with no use, whereas recent (adjusted rate ratio [RR], 0.87; 95% CI, 0.66 - 1.16) and past (adjusted RR, 0.86; 95% CI, 0.66 - 1.12) fluoroquinolone use were not linked to acute kidney injury risk.

The authors excluded men with a history of chronic kidney disease or dialysis. They used logistic regression to calculate rate ratios, adjusting for fluoroquinolone indication, diseases associated with acute kidney injury, potentially nephrotoxic drugs with high use, and markers of healthcare use.

When they looked at individual drugs, they saw that ciprofloxacin was associated with a higher risk for acute kidney injury (RR, 2.76; 95% CI, 2.03 - 3.76), as were moxifloxacin (RR, 2.09; 95% CI, 1.04 - 4.20), and levofloxacin (RR, 1.69; 95% CI, 1.20 - 2.39). In contrast, neither amoxicillin (RR, 0.79; 95% CI, 0.49 - 1.26) nor azithromycin (RR, 1.06; 95% CI, 0.68 - 1.66) showed an association with acute kidney injury.

In a case-time-control analysis, fluoroquinolones (RR, 2.16; 95% CI, 1.52 - 3.18), but not amoxicillin (RR, 0.65; 95% CI, 0.38 - 1.05) or azithromycin (RR, 1.06; 95% CI, 0.62 - 1.90), were associated with a higher risk for acute kidney injury.

Although renin-angiotensin system blockers alone were not associated with an increased risk for acute kidney injury (RR, 1.00; 95% CI, 0.84 - 1.18), the combined use of fluoroquinolones and renin-angiotensin system blockers was associated with a greater risk for acute kidney injury (RR, 4.46; 95% CI, 2.84 - 6.99).

The limitations of the study include a lack of information on kidney injury severity, an inability to assess the risk associated with the dosage or duration of treatment, and residual confounding inherent to observational research.

"We found a twofold increased risk of acute kidney injury requiring hospital admission with the use of fluoroquinolone antibiotics among adult men, using 2 analytic techniques," the authors write. "Although it is clear that the risk of death due to serious infections outweighs the risks associated with the use of fluoroquinolones, the potential for acute kidney injury raises the importance of vigilant prescribing."

The study was supported by funding from the McGill University Health Centre, Fonds de la Recherche en Santé du Québec, and the Ministère de la Santé et des Services Sociaux. One coauthor received financial support from le Fonds de la Recherche en Santé du Québec. One coauthor received financial support from the Agency for Healthcare Research and Quality. One coauthor is the principal investigator for the Observational Medical Outcomes Partnership. The other authors have disclosed no relevant financial relationships.

CMAJ. Published online June 3, 2013.

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