Study Reaffirms Safety of Acetaminophen

Data Show Recommended Daily Doses of Acetaminophen

Not Linked to Liver Injury in Alcoholics

Oct 07, 2001, 01:00 ET from Denver Health

    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
 appropriate treatment.
     "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