DENVER, Oct. 7 /PRNewswire/ -- Results of a study published in today's
issue of the American Medical Association's "Archives of Internal Medicine"*
show repeated use of the maximum recommended daily dose of acetaminophen, the
medicine in Tylenol(R), is not associated with evidence of liver (hepatic)
injury -- even in high-risk patients.
Physician researchers at Denver Health's Rocky Mountain Poison & Drug
Center, who serve on the faculty of the University of Colorado Health Sciences
Center (UCHSC) in Denver, conducted the randomized, double-blind,
placebo-controlled trial to determine the effects of therapeutic doses of
acetaminophen on the liver of 201 alcoholic patients immediately following
cessation of alcohol use.
"Our study is the largest prospective study of its kind to date," says
lead researcher Edwin K. Kuffner, MD, Toxicologist, Rocky Mountain Poison and
Drug Center, Denver. "We found that therapeutic doses of acetaminophen are
safe, even in high-risk populations such as alcoholics,"
Dr. Kuffner notes that in recent years, reports based on retrospective
reviews of existing data have suggested that alcoholic patients may be at risk
of liver injury after taking recommended doses of acetaminophen
"All of these retrospective reviews contained serious flaws," says Dr.
Kuffner. "Either they relied on the patient's history to estimate the dose of
acetaminophen ingested or failed to consider other potential causes of liver
Dr. Kuffner adds that the researchers at UCHSC designed their study to
avoid these pitfalls. Patients in the acetaminophen group received 4000 mg
(the maximum recommended daily dosage) orally, for two consecutive days.
Liver tests were administered during the subsequent two days to detect small
changes in liver enzyme levels. Acetaminophen was not administered until
alcohol had been eliminated from each patient.
Despite the generally recognized weaknesses of retrospective data, some
authors have continued to use these retrospective reviews to recommend that
alcoholic patients reduce doses of acetaminophen or avoid the drug. Richard
C. Dart, MD, PhD, study co-author, and Director, Rocky Mountain Poison and
Drug Center, Denver, cautions that such assertions create confusion about
"In my opinion, acetaminophen is the safest over-the-counter pain reliever
available," says Dr. Dart. "The other choices a patient has include aspirin,
ibuprofen, and other nonsteroidal anti-inflammatory agents (NSAIDs). Even at
therapeutic doses, the NSAIDs have much more severe risk profiles than
acetaminophen and are much more difficult to treat in overdose."
Dr. Dart adds that clinical data indicate that aspirin in particular can
cause stomach irritation and bleeding, even in the absence of alcohol; however
the risk of serious stomach bleeding associated with aspirin is at least
double in the presence of alcohol.
According to Dr. Dart, further research is needed to explore the safety of
over-the-counter pain relievers in alcoholics and other high-risk patients.
This research was supported by a grant from McNeil Consumer Healthcare,
maker of Tylenol(R).
Denver Health integrates acute hospital and emergency care with public and
community health and includes Denver Health Medical Center, Denver's 911
system, Denver Paramedic Division, 11 family health centers, 12 school-based
health centers, Rocky Mountain Poison and Drug Center, Correctional Care,
Denver CARES, the Public Health Department, Denver Health Foundation and
Denver Health Medical Plan.
* Kuffner, EK, Dart RC, Bogdan, GM, et al: Effect of Maximal Daily Doses
of Acetaminophen on the Liver of Alcoholic Patients: A Randomized Double Blind
Controlled Trial. Archives of Internal Medicine October 2001
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SOURCE Denver Health