Acetaminophen use in patients who drink alcohol: current study evidence.

Package labeling for all over-the-counter pain relievers and fever reducers warns patients who drink 3 or more alcoholic beverages daily to consult with a physician before using these products. In the absence of accurate, consistent data, physicians have relied on retrospective and anecdotal evidence, which has perhaps led to greater restrictions on acetaminophen use than necessary for patients who consume alcohol. Recently, a well-controlled clinical study was conducted to more rigorously characterize the risk to alcohol users taking acetaminophen. In this randomized, double-blind, placebo-controlled trial, patients enrolled in a drug detoxification facility received 1000 mg acetaminophen or placebo 4 times daily for 2 consecutive days immediately after discontinuing alcohol use. Serum aspartate aminotransferase and alanine aminotransferase levels, used to detect hepatic necrosis or liver disease, were monitored at baseline and again both during and after the study. Results for 201 patients completing the study showed no statistically significant difference in liver function tests for 102 patients receiving acetaminophen compared with 99 patients receiving placebo. Researchers concluded that there was no increase in liver toxicity among alcoholic patients given the maximal therapeutic dose (4 g/day) of acetaminophen and no clinical evidence of increased risk for these patients when acetaminophen is used within recommended doses.