Hepatitis C Information Central

Over-the-counter drug manufacturers of Tylenol and other pain relievers have agreed to publish a warning for those who consume three or more alcoholic drinks per day to consult a physician before using these products.

The warning on the product containers is in response to a Food and Drug Administration recommendation after a 1993 hearing at which the American Liver Foundation testified on the need to alert consumers about the possibility of liver damage if alcohol and acetaminophen are combined.

Tylenol, the most popular product containing acetaminophen, has been used safely by millions of people since 1960.

Recent reports in the medical literature have highlighted the possible danger to the liver in the use of acetaminophen by alcoholics and those fasting.

In addition there are rare instances documented by Hyman J. Zimmerman, M.D., Professor of Medicine Emeritus at George Washington University, of alcoholics who suffered liver damage by consuming more, and in a number of instances less, than the recommended dosage.

In a registry of 67 patients compiled by Dr. Zimmerman, 40% of the alcoholics with liver damage consumed less than the recommended dosage of four grams per day.

"This study provides further evidence of hepatic injury in regular users of alcohol, especially chronic alcoholics," Dr. Zimmerman wrote in a paper that has been submitted for publication.

Despite the agreement to publish the warning, McNeil Laboratories, the manufacturers of Tylenol, only acknowledge that chronic, heavy alcohol abusers "may be at increased risk."

This possible "increased risk of liver toxicity" by chronic alcoholics is "from excessive acetaminophen use, although reports of this even are rare," Bonnie J. Johnson, Ph.D. a medical information specialist for McNeil, told the Foundation.

"Reports almost invariably involve cases of severe chronic alcoholics," Dr. Johnson said, "and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose."

The American Liver Foundation is developing a comprehensive policy on acetaminophen and alcohol.

Copyright © 1997 The American Liver Foundation