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Risk for acute liver injury linked to moxifloxacin, levofloxacin

Certain fluoroquinolones may be associated with an increased risk for acute liver injury, according to recent results.

In a population-based, nested case-control study, researchers evaluated 144 patients aged 66 years or older admitted to a hospital for acute liver injury (ALI) within 30 days of receiving a prescription for moxifloxacin (n=26), levofloxacin (n=23), ciprofloxacin (n=54) or cefuroxime axetil (n=14), with patients taking clarithromycin (n=27) used as a reference point. Each case was matched to as many as 10 patients who received one of these antibiotics but was not admitted for liver injury for a total of 1,409 controls.

Across the cohort, approximately 2.86 million courses of antibiotics were administered, and 172 hospital admissions for acute liver injury occurred, including several cases of multiple admissions. In-hospital death occurred in 88 patients. Crude incidences for admission among patients receiving moxifloxacin (7.98 per 100,000 exposures) and levofloxacin (8.62 per 100,000 exposures) were higher than that for patients receiving clarithromycin (3.95 per 100,000 exposures).

Through multivariate analysis, investigators determined an association between acute liver injury and moxifloxacin (adjusted OR=2.20, 95% CI, 1.21-3.98) and levofloxacin (adjusted OR=1.85, 95% CI, 1.01-3.39), but not with ciprofloxacin (adjusted OR=1.56, 95% CI, 0.95-2.58) or cefuroxime axetil (adjusted OR=1.43, 95% CI, 0.72-2.83), compared to those receiving clarithromycin. A lower median household income was also associated with increased risk for ALI, after adjusting for other confounders. After excluding patients who lived in long-term care facilities, the associations with moxifloxacin and levofloxacin grew stronger (adjusted OR=2.74, 1.42-5.29 for moxifloxacin and 2.29, 1.17-4.46 for levofloxacin; 95% CI for both).

“Among older outpatients with no evidence of liver disease, moxifloxacin and levofloxacin were associated with an increased risk of acute liver injury relative to clarithromycin,” the researchers concluded. “… Although our results require confirmation in other settings, they suggest that both moxifloxacin and levofloxacin be considered for regulatory warnings regarding acute liver injury.”

Disclosure: See the study for a full list of relevant financial disclosures.