Are recommended doses of acetaminophen hepatotoxic for recently abstinent alcoholics? A randomized trial

References

• Peura D, Lanza F, Gostout C. The American College of Gastroenterology Bleeding Registry: Preliminary findings. Am J Gastroenterol 1997; 92: 924–8
   PubMed Web of Science ®Google Scholar
• Ostapowicz G, Fontana R, Schiodt F, Larson A, Davern T, Han S, McCashland T, Shakil A, Hay J, Hyman L, Crippin J, Blei A, Samuel G, Reisdi J, Lee W. U.S. Acute Liver Failure Study Group. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med 2002; 137(12)947–54
   PubMed Web of Science ®Google Scholar
• Hawton K, Townsend E, Deeks J, Appleby L, Gunnell D, Bennewith O, Cooper J. Effects of legislation restricting pack sizes of paracetamol and salicylate on self poisoning in the United Kingdom: Before and after study. BMJ 2001; 322(7296)1203–7
   PubMed Web of Science ®Google Scholar
• Rumack B, Peterson R, Koch G, Amara I. Acetaminophen overdose. 662 cases with evaluation of oral acetylcysteine treatment. Arch Intern Med 1981; 141(3)380–385
   PubMedGoogle Scholar
• Schmidt L, Dalhoff K, Poulsen H. Acute versus chronic alcohol consumption in acetaminophen-induced hepatotoxicity. Hepatology 2002; 35(4)876–82
   PubMed Web of Science ®Google Scholar
• Schiodt F, Lee W, Bondesen S, Ott P, Christensen E. Influence of acute and chronic alcohol intake on the clinical course and outcome in acetaminophen overdose. Aliment Pharmacol Ther 2002; 16(4)707–15
   PubMed Web of Science ®Google Scholar
• Whitcomb D, Block G. Association of acetaminophen hepatotoxicity with fasting and ethanol use. JAMA 1994; 272(23)1845–50
   PubMed Web of Science ®Google Scholar
• Bray G, Mowat C, Muir D, Tredger J, Williams R. The effect of chronic alcohol intake on prognosis and outcome in paracetamol overdose. Hum Exp Toxicol 1991; 10(6)435–8
   PubMed Web of Science ®Google Scholar
• Sivilotti ML, Yarema MC, Juurlink DN, Good AM, Johnson DW. A Risk quantification instrument for acute acetaminophen overdose patients treated with n-acetylcysteine. Ann Emerg Med 2005; 46(3)263–71
   PubMed Web of Science ®Google Scholar
• Thummel K, Slattery J, Ro H, Chien J, Nelson S, Lown K, Watkins P. Ethanol and production of the hepatotoxic metabolite of acetaminophen in healthy adults. Clin Pharmacol Ther 2000; 67(6)591–9
   PubMed Web of Science ®Google Scholar
• Prescott L. Paracetamol, alcohol and the liver. Br J Clin Pharmacol 2000; 49(4)291–301
   PubMed Web of Science ®Google Scholar
• Lauterburg B, Velez M. Glutathione deficiency in alcoholics: Risk factors for paracetamol hepatotoxicity. Gut 1988; 29: 1153–7
   PubMed Web of Science ®Google Scholar
• Kozer E, Koren G. Management of paracetamol overdose: Current controversies. Drug Saf 2001; 24(7)503–12
   PubMed Web of Science ®Google Scholar
• Buckley N, Srinivasan J. Should a lower treatment line be used when treating paracetamol poisoning in patients with chronic alcoholism?: A case for. Drug Saf 2002; 25(9)619–24
   PubMed Web of Science ®Google Scholar
• Schiodt F, Rochling F, Casey D, Lee W. Acetaminophen toxicity in an urban county hospital. N Engl J Med 1997; 337(16)1112–7
   PubMed Web of Science ®Google Scholar
• Heubi JE, Barbacci MB, Zimmerman HJ. Therapeutic misadventures with acetaminophen: Hepatoxicity after multiple doses in children. J Pediatr 1998; 132(1)22–7
   PubMed Web of Science ®Google Scholar
• Maddrey WC. Hepatic Effects of acetaminophen. Enhanced toxicity in alcoholics. J Clin Gastroenterol 1987; 9(2)180–5
   PubMed Web of Science ®Google Scholar
• Makin A, Williams R. Paracetamol hepatotoxicity and alcohol consumption in deliberate and accidental overdose. QJM 2000; 93(6)341–9
   PubMed Web of Science ®Google Scholar
• Kuffner E, Bogdan G, Dart R. Evaluation of hepatotoxicity in alcoholics from therapeutic dosing of acetaminophen. J Toxicol Clin Toxicol 1999; 37: 641A
   Google Scholar
• Makin A, Wendon J, Williams R. A 7-year experience of severe acetaminophen-induced hepatotoxicity (1987–1993). Gastroenterology 1995; 109(6)1907–1916
   PubMed Web of Science ®Google Scholar
• Dart R, Kuffner E, Rumack BH. Treatment of pain or fever with paracetamol (acetaminophen) in the alcoholic patient: A systematic review. Am J Ther 2000; 7(2)123–34
   PubMedGoogle Scholar
• Zimmerman H, Maddrey W. Acetaminophen (paracetamol) heptotoxicity with regular intake of alcohol: Analysis of instances of therapeutic misadventure. Hepatology 1995; 22: 767–73
   PubMed Web of Science ®Google Scholar
• Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-counter Human Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labelling. Federal Register Dec 26 2006; 71(247)77314–77352
   Google Scholar
• Holtzman JL. The effect of alcohol on acetaminophen hepatotoxicity. Arch Int Med 2002; 162: 1193
   PubMed Web of Science ®Google Scholar
• Soll AH, Sees KL. Is Acetaminophen Really Safe in Alcoholic Patients?. Arch Int Med. 2002; 162: 1194
   PubMed Web of Science ®Google Scholar
• Watkins PB, Kaplowitz N, Slattery JT, Colonese CR, Colucci SV, Stewart PW, Harris SC. Aminotransferase elevations in healthy adults receiving 4 grams of acetaminophen daily: A randomized controlled trial. JAMA 2006; 296(1)87–93
   PubMed Web of Science ®Google Scholar
• Sivilotti M, Burns M, Linden C, Aaron C. Alpha-GST as a biomarker of acetaminophen-induced hepatotoxicity. Clin Toxicol 1999; 37(5)641
   Google Scholar
• Sivilotti M, Bird S, Montalvo M, Aaron C, Brison R, Linden C. Serum-glutathione s-transferase becomes elevated shortly after subtoxic acetaminophen overdose. Emerg Med J 2002; 19(suppl. 1)A12
   Google Scholar
• Beckett GJ, Chapman BJ, Dyson EH, Hayes JD. Plasma glutathione s-transferase measurements after paracetamol overdose: Evidence for early hepatocellular damage. Gut 1985; 26(1)26–31
   PubMed Web of Science ®Google Scholar
• Beckett GJ, Foster GR, Hussey AJ, Oliveira DB, Donovan JW, Prescott LF, Proudfoot A. Plasma glutathione s-transferase and F protein are more sensitive than alanine aminotransferase as markers of paracetamol (acetaminophen)-induced liver damage. Clin Chem 1989; 35(11)2186–9
   PubMed Web of Science ®Google Scholar
• Beckett GJ, Donovan JW, Hussey AJ, Proudfoot AT, Prescott LF. Intravenous n-acetylcysteine, hepatotoxicity and plasma glutathione s-transferase in patients with paracetamol overdosage. Hum Exp Toxicol 1990; 9(3)183–6
   PubMed Web of Science ®Google Scholar
• Shaw M. The use of histologically defined specific biomarkers in drug development with special reference to the glutathione s-transferases. Cancer Biomarkers 2005; 1: 69–74
   PubMedGoogle Scholar
• Cary N. The MIXED procedure. SAS/STAT User's Guide8th. SAS Institute Inc. 1999
   Google Scholar
• Mulder TP, Janssens AR, de Bruin WC, Peters WH, Cooreman MP, Jansen JB. Plasma glutathione s-transferase alpha 1-1 levels in patients with chronic liver disorders. Clin Chim Acta 1997; 258(1)69–77
   PubMed Web of Science ®Google Scholar
• Hayes PC, Hayes JD, Hussey AJ, Bouchier IAD, Beckett GJ. Changes in plasma glutathione s-transferase concentration after alcohol ingestion in man: A measure of hepatocellular sensitivity to chronic alcohol excess. Clin Chem Enzyme Commun 1990; 2: 189–194
   Google Scholar
• Beckett GJ, Hayes PC, Hussey AJ, Bouchier IA, Hayes JD. Plasma glutathione s-transferase measurements in patients with alcoholic cirrhosis. Clin Chim Acta 1987; 169: 85–89
   PubMed Web of Science ®Google Scholar
• Loguercio C, de Girolamo V, Cuomo A, Argenzio F, Iannotta C, DiSalvo D, Grella A, del Vecchio Blanco L. Determination of plasma a-glutathione-S-transferases in chronic alcohol abusers: relationship with alcohol intake and liver involvement. Alcohol & Alcoholism 1998; 33(4)366–372
   PubMed Web of Science ®Google Scholar
• Larrey D. Drug-induced liver diseases. J Hepatol 2000; 32(1 suppl)77–88
   PubMedGoogle Scholar
• Ballet F. Hepatotoxicity in drug development: Detection, significance and solutions. J Hepatol 1997; 26(suppl. 2)26–36
   PubMed Web of Science ®Google Scholar
• Temple AR, Benson GD, Zinsenheim JR, Schweinle JE. Multicenter, randomized, double-blind, active-controlled, parallel-group trial of the long-term (6–12 months) safety of acetaminophen in adult patients with osteoarthritis. Clin Ther 2006; 28(2)222–35
   PubMed Web of Science ®Google Scholar
• Bradley JD, Brandt KD, Katz BP, Kalasinski LA, Ryan SI. Comparison of an antiinflammatory dose of ibuprofen, an analgesic dose of ibuprofen, and acetaminophen in the treatment of patients with osteoarthritis of the knee. NEJM 1991; 325(2)87–91
   PubMed Web of Science ®Google Scholar
• Kwan D, Bartle WR, Walker SE. Abnormal serum transaminases following therapeutic doses of acetaminophen in the absence of known risk factors. Dig Dis Sci 1995; 40(9)1951–5
   PubMed Web of Science ®Google Scholar
• Kwan D, Bartle WR, Walker SE. The effects of acetaminophen on pharmacokinetics and pharmacodynamics of warfarin. J Clin Pharmacol 1999; 39(1)68–75
   PubMed Web of Science ®Google Scholar
• Seeff L, Cuccherini B, Zimmerman H. Acetaminophen hepatotoxicity in alcoholics. Ann Intern Med 1986; 104: 399–404
   PubMed Web of Science ®Google Scholar
• Prescott L. Therapeutic misadventure with paracetamol: Fact or fiction?. Am J Ther 2000; 7(2)99–114
   PubMedGoogle Scholar
• Benson G. Acetaminophen in chronic liver disease. Clin Pharmacol Ther 1983; 33: 95–101
   PubMed Web of Science ®Google Scholar
• Kuffner E, Dart R, Bogdan G. Evaluation of hepatotoxicity in alcoholic patients from therapeutic dosing of acetaminophen. J Toxicol Clin Toxicol 1997; 35(5)561
   Google Scholar
• Kuffner EK, Dart RC, Bogdan GM, Hill RE, Casper E, Darton L. Effect of maximal daily doses of acetaminophen on the liver of alcoholic patients: A randomized, double-blind, placebo-controlled trial. Arch Intern Med. 2001; 161(18)2247–52
   PubMed Web of Science ®Google Scholar
• Green J, Kuffner E, Bogdan B, Dart R. Hepatic function in alcoholics throughout 4 days of maximal therapeutic dosing of acetaminophen (APAP). J Toxicol Clin Toxicol 2005; 43: 683
   Google Scholar
• Andreasen P, Hutters L. Paracetamol (acetaminophen) clearance in patients with cirrhosis of the liver. Acta Med Scand Suppl 1979; 624: 99–105
   PubMedGoogle Scholar
• Forrest J, Adriaenssens P, Finlayson N, Prescott L. Paracetamol metabolism in chronic liver disease. Eur J Clin Pharmacol 1979; 15: 427–31
   PubMed Web of Science ®Google Scholar
• Skinner M, Matano R, Hazle W, Blaschke T. Acetaminophen metabolism in recovering alcoholics. Meth Find Exp Clin Pharmacol 1990; 12(7)513–2
   PubMed Web of Science ®Google Scholar
• Hayes PC, Bouchier IA, Beckett GJ. Glutathione s-transferase in humans in health and disease. Gut 1991; 32(7)813–8
   PubMed Web of Science ®Google Scholar
• Beckett GJ, Hayes JD. Glutathione s-transferases: Biomedical applications. Adv Clin Chem 1993; 30: 281–380
   PubMed Web of Science ®Google Scholar
• Trull AK, Facey SP, Rees GW, Wight DG, Noble-Jamieson G, Joughin C, Friend PJ, Alexander GJ. Serum alpha-glutathione s-transferase-a sensitive marker of hepatocellular damage associated with acute liver allograft rejection. Transplantation 1994; 58(12)1345–51
   PubMed Web of Science ®Google Scholar
• Hussey AJ, Howie J, Allan LG, Drummond G, Hayes JD, Beckett GJ. Impaired hepatocellular integrity during general anaesthesia, As assessed by measurement of plasma glutathione s-transferase. Clin Chim Acta 1986; 161(1)19–28
   PubMed Web of Science ®Google Scholar
• Clarke H, Egan DA, Heffernan M, Doyle S, Byrne C, Kilty C, et al. Alpha-glutathione s-transferase (Alpha-GST) release, an early indicator of carbon tetrachloride hepatotoxicity in the rat. Hum Exp Toxicol 1997; 16(3)154–7
   PubMed Web of Science ®Google Scholar
• Stork C, Rees S, Howland M, Kaplan L, Goldfrank L, Hoffman R. Pharmacokinetics of extended relief vs. regular release Tylenol in simulated human overdose. Clin Toxicol 1996; 34(2)157–62
   Web of Science ®Google Scholar