Q&A

Does acetaminophen affect liver function in alcoholic patients?

J Fam Pract. 2003 March;52(3):183-200
By
Joseph J. Saseen, PharmD
Author and Disclosure Information

  • BACKGROUND: Traditionally, acetaminophen use in alcoholics has been discouraged due to uncontrolled retrospective data (mostly case reports) that suggest drug-induced hepatotoxicity with therapeutic doses.
  • POPULATION STUDIED: This study included 201 alcoholic patients at least 18 years of age who had entered an alcohol detoxification facility in Denver, Colorado. Patients were excluded if baseline laboratory values were abnormal (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] levels >120 U/L, international normalized ratio [INR] >1.5, or serum acetaminophen concentration >20 mg/L), if they had a history of ingesting more than 4000 mg/d of acetaminophen within 4 days of enrollment, an allergy to acetaminophen, were enrolled in any other trial within the previous 3 months, or were intoxicated with alcohol at the time the first dose of study medication was administered.
  • STUDY DESIGN AND VALIDITY: This was a randomized, double-blind, controlled study. Allocation to treatment group (determined with computer software) was concealed from the investigator involved with patient evaluations and care.
  • OUTCOMES MEASURED: The primary outcomes measured were changes in liver function tests (AST, ALT, and INR) at baseline, 2 days after acetaminophen use, and 2 days after stopping acetaminophen.
  • RESULTS: Overall, 102 patients randomized to receive acetaminophen and 99 patients randomized to receive placebo completed the study. There were no statistically significant differences in demographic or baseline laboratory values between groups. Mean AST, ALT, and INR values did not differ between groups. Time-dependent changes in INR were not seen (P=.07).
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PRACTICE RECOMMENDATIONS

Acetaminophen in doses of 4 g/d did not affect liver function of alcoholic patients in this randomized study.

These results do not rule out the possibility of acetaminophen-induced liver failure in alcoholic patients, especially patients with pre-existing liver disease or those who continue to drink. Patient-oriented outcomes (ie, studying chronic acetaminophen use in alcoholics to determine the incidence of developing hepatic failure) ultimately would resolve this controversy.

However, these data do cast doubt on the medical myth (based on case reports) that acetaminophen use in alcoholics causes hepatotoxicity.

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