Risk of hepatotoxicity associated with fluoroquinolones: A national case–control safety study

• Published in: American journal of health-system pharmacy 2014-01, Vol.71 (1), p.37-43
• Main Authors: ALSHAMMARI, THAMIR M, LARRAT, E PAUL, MORRILL, HALEY J, CAFFREY, AISLING R, QUILLIAM, BRIAN J, LAPLANTE, KERRY L
• Format: Article
• Language: English
• Subjects: Adult; Aged; Alcoholism - complications; Alcoholism - epidemiology; Anti-Bacterial Agents - adverse effects; Aza Compounds - adverse effects; Biological and medical sciences; Case-Control Studies; Chemical and Drug Induced Liver Injury - epidemiology; Ciprofloxacin - adverse effects; Comorbidity; Complications and side effects; Data Interpretation, Statistical; Databases, Factual; Drug toxicity and drugs side effects treatment; Female; Fluoroquinolones - adverse effects; Hospitals, Veterans; Humans; Levofloxacin - adverse effects; Liver diseases; Male; Medical sciences; Middle Aged; Moxifloxacin; Patient Safety; Pharmacology. Drug treatments; Quinolines - adverse effects; Quinolone antibacterial agents; Quinolones; Retrospective Studies; Risk Factors; Socioeconomic Factors; Toxicity: digestive system; United States; United States Department of Veterans Affairs
• ISSN: 1079-2082; 1535-2900
• DOI: 10.2146/ajhp130165

PURPOSEResults of a pharmacoepidemiologic evaluation of fluoroquinolone-associated hepatotoxicity using national hospital admissions data on Veterans Affairs (VA) patients are reported. METHODSIn a retrospective case–control study, all adults with a primary diagnosis of hepatotoxicity on admission to a VA facility during a 6.5-year period (January 2002–June 2008) were identified. After the exclusion of patients whose records indicated known causes of hepatotoxicity or a history of liver disease, a subgroup of 7,862 patients with exposure to fluoroquinolone antibiotics in the six months prior to hospital admission were matched with nonexposed controls (n = 45,512). Conditional logistic regression was used to assess the overall and drug-specific risks of hepatotoxicity in the case group, controlling for comorbidities, concomitant use of known hepatotoxic medications, and other variables. RESULTSAfter adjusting for confounders, logistic regression analysis indicated a significantly higher overall risk of hepatotoxicity development among fluoroquinolone users relative to controls (odds ratio [OR], 1.20; 95% confidence interval [CI], 1.04–1.38). Drug-specific risk analyses focused on three fluoroquinolone agents (ciprofloxacin, levofloxacin, and moxifloxacin) indicated a significant association between ciprofloxacin use and an increased risk of hepatotoxicity (OR, 1.29; 95% CI, 1.05–1.58); when considered as independent variables, levofloxacin use and moxifloxacin use were not significantly associated with hepatotoxicity risk. CONCLUSIONThe findings of a national VA safety study suggested an increased hepatotoxicity risk asssociated with fluoroquinolone exposure in the study population.