Fluoroquinolone therapy and idiosyncratic acute liver injury: a population-based study
Open accessAbstract
BACKGROUND: Although fluoroquinolones are sometimes associated with mild, transient elevations in aminotransferase levels, serious acute liver injury is uncommon. Regulatory warnings have identified moxifloxacin as presenting a particular risk of hepatotoxicity. Thus, we examined the risk of idiosyncratic acute liver injury associated with the use of moxifloxacin relative to other selected antibiotic agents. METHODS: We conducted a population-based, nested, case-control study using health care data from Ontario for the period April 2002 to March 2011. We identified cases as outpatients aged 66 years or older with no history of liver disease, and who were admitted to hospital for acute liver injury within 30 days of receiving a prescription for 1 of 5 broad-spectrum antibiotic agents: moxifloxacin, levofloxacin, ciprofloxacin, cefuroxime axetil or clarithromycin. For each case, we selected up to 10 age- and sex-matched controls from among patients who had received a study antibiotic, but who were not admitted to hospital for acute liver injury. We calculated odds ratios (ORs) to determine the association between admission to hospital and previous exposure to an antibiotic agent, using clarithromycin as the reference. RESULTS: A total of 144 patients were admitted to hospital for acute liver injury within 30 days of receiving a prescription for one of the identified drugs. Of these patients, 88 (61.1%) died while in hospital. After multivariable adjustment, use of either moxifloxacin (adjusted OR 2.20, 95% confidence interval [CI] 1.21-3.98) or levofloxacin (adjusted OR 1.85, 95% CI 1.01-3.39) was associated with an increase in risk of acute liver injury relative to the use of clarithromycin. We saw no such risk associated with the use of either ciprofloxacin or cefuroxime axetil. INTERPRETATION: 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.
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- Authors
- Paterson, J. M., Mamdani, M. M., Manno, M., & Juurlink, D. N.
- Affiliations
- St. Michael's Hospital (CA)
- Venue
- Canadian Medical Association Journal
- Publisher
- CMA Impact Inc.
- Published
- 2012-08-13
- Volume
- 184
- Issue
- 14
- Pages
- 1565-1570
- ISSN
- 0820-3946 (ISSN-L)
- 1488-2329
- PMC
- PMC3470619
- OpenAlex
- W2096871000
- Cited by
- 62
- References
- 26
- Citations by year
- 2026: 1 · 2025: 5 · 2024: 2 · 2023: 4 · 2022: 7 · 2021: 8 · 2020: 4 · 2019: 4 · 2018: 6 · 2017: 4 · 2016: 5 · 2015: 2 · 2014: 3 · 2013: 6 · 2012: 1
- FWCI
- 4.34
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Canadian Medical Association Journal (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- GlaxoSmithKline
- Institute for Clinical Evaluative Sciences
- Ontario Ministry of Health and Long-Term Care
- Novo Nordisk
- Canadian Institutes of Health Research
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Nephrology › Acute Kidney Injury Research
- Keywords
- fluoroquinolones, drug-induced liver injury, moxifloxacin, levofloxacin, ciprofloxacin, clarithromycin, cefuroxime axetil, hepatotoxicity, older adults, broad-spectrum antibiotics, hospitalization
- MeSH terms
- Moxifloxacin, Acute Disease, Aged, Aged, 80 and over, Anti-Bacterial Agents, Aza Compounds, Female, Humans, Male, Quinolines, Case-Control Studies, Fluoroquinolones, Chemical and Drug Induced Liver Injury
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Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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