Drug-induced liver injury due to varenicline: a case report

• Published in: BMC gastroenterology Vol. 12; no. 1; p. 65
• Main Authors: Sprague, David, Bambha, Kiran
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 08.06.2012; BioMed Central; BMC
• Subjects: Abdomen; Aged; Alanine Transaminase - metabolism; Alkaline Phosphatase - metabolism; Aspartate Aminotransferases - metabolism; Benzazepines - adverse effects; Benzazepines - therapeutic use; Care and treatment; Case Report; Chemical and Drug Induced Liver Injury - diagnosis; Chemical and Drug Induced Liver Injury - etiology; Colleges & universities; Complications and side effects; Consent; Drug induced liver injury; Enzymes; Family medical history; Gastroenterology; Hepatitis; Hepatitis C; Hepatology; Hispanic Americans; Humans; Hypertension; Idiosyncratic; International Normalized Ratio; Liver; Liver - metabolism; Liver - physiopathology; Liver cirrhosis; Liver diseases; Male; Nicotinic Agonists - adverse effects; Nicotinic Agonists - therapeutic use; Nonprescription drugs; Patient outcomes; Phosphatases; Primary care; Quinoxalines - adverse effects; Quinoxalines - therapeutic use; Smoking cessation; Smoking Cessation - methods; Smoking cessation programs; Type 2 diabetes; Varenicline; Withholding Treatment; Timor-Leste; United States > US
• ISSN: 1471-230X; 1471-230X
• DOI: 10.1186/1471-230X-12-65

Liver injury due to prescription and nonprescription medications is an expanding public health concern in the United States, with drug-induced liver injury (DILI) being the single most common reason for regulatory actions instituted by the Food and Drug Administration against certain medications and supplements. A 69-year-old Latino man was referred to Hepatology Clinic for urgent evaluation of new onset jaundice, nausea and fatigue associated with a >40-fold increase in his transaminase levels and elevated INR and alkaline phosphatase. The patient had received a new prescription for varenicline to aid with smoking cessation approximately 3 weeks prior to his evaluation in Hepatology Clinic. Within 5 days of starting the varenicline, the patient developed new onset of nausea, vomiting, malaise and deep jaundice. The varenicline was discontinued on day 5 by the patient. Hepatologic evaluation revealed no evidence of acute viral hepatitis, autoimmune, metabolic or alcohol-related liver disorders. The patient's past medical history was notable, however, for chronic hepatitis C. His liver enzymes and synthetic function completely normalized 9 weeks after discontinuation of the varenicline. This report represents the second documented cases of drug-induced liver injury related to varenicline therapy, highlighting the need for clinician awareness regarding potential hepatotoxicity of varenicline, particularly among patients with pre-existing liver disease.