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


METHODS
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.


CONCLUSIONS
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.
Department of Internal Medicine, University of Colorado Denver, Aurora, CO, USA.
David
D
Sprague
Kiran
K
Bambha
D000368:Aged; D000410:Alanine Transaminase / Q000378:metabolism; D000469:Alkaline Phosphatase / Q000378:metabolism; D001219:Aspartate Aminotransferases / Q000378:metabolism; D001552:Benzazepines / Q000009:adverse effects* / Q000627:therapeutic use; D056486:Chemical and Drug Induced Liver Injury / Q000175:diagnosis* / Q000209:etiology*; D006801:Humans; D019934:International Normalized Ratio; D008099:Liver / Q000378:metabolism / Q000503:physiopathology; D008297:Male; D018722:Nicotinic Agonists / Q000009:adverse effects* / Q000627:therapeutic use; D011810:Quinoxalines / Q000009:adverse effects* / Q000627:therapeutic use; D016540:Smoking Cessation / Q000379:methods*; D000068580:Varenicline; D028761:Withholding Treatment
D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase; D000068580:Varenicline