Acetaminophen, When Taken as Directed, is Safe for Patients with Liver Disease

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Acetaminophen, When Taken as Directed, is Safe for Patients with Liver Disease

Ft. Washington, PA (March 17, 2005) - Contrary to common perception, clinical

data demonstrate that acetaminophen is an appropriate pain relief choice for

patients with chronic liver disease. According to a systematic literature review

of the data, which is published in the current issue of the American Journal of

Therapeutics, there is no evidence that acetaminophen at therapeutic doses

aggravates liver disease.

Studies showed that patients with liver disease are able to metabolize

acetaminophen appropriately. The review article concludes that acetaminophen at

recommended doses, when taken as directed, can be used safely in patients with

liver disease and is a preferred analgesic because it lacks the gastrointestinal

toxicity, renal toxicity and inhibitory actions on platelet aggregation

associated with aspirin and other nonsteroidal anti-inflammatory drugs

(NSAIDs).1

" The results of this review refute the popular misconception that liver disease

patients should avoid using acetaminophen to manage their pain, " said lead

author Dr. Gordon Benson, professor emeritus, Department of Medicine, University

of Medicine and Dentistry of New Jersey Wood Medical School.

" Liver toxicity with acetaminophen appears to occur only in those who consume an

overdose of the drug. "

The studies included in the systematic literature review demonstrated:

a.. Administration of the maximum recommended dose (4 g / d) of acetaminophen

for 13 days to 20 patients with stable chronic liver disease did not result in

any evidence of toxicity.2

b.. In patients with chronic hepatitis C, administration of acetaminophen (3 g

/ d for seven days) did not affect serum levels of alanine aminotransferase (a

common liver function test).3

c.. Repeated administration of the maximum recommended acetaminophen dose for

over five days to six patients with chronic liver disease did not lead to

accumulation.4

d.. Available studies in patients with chronic liver disease have shown that

although the half-life of acetaminophen may be prolonged, cytochrome P-450

(CYP2E1) enzyme activity is not increased and glutathione stores are not

depleted to critical levels in patients taking recommended doses.

Alcohol-associated acetaminophen hepatotoxicity has not been reported in

prospective studies of alcoholics taking therapeutic doses of acetaminophen. To

date, there have been no prospective studies evaluating use of acetaminophen in

chronic drinkers with underlying liver disease.

" These study data provide a better understanding of how patients with liver

disease are able to metabolize acetaminophen, without increased risk of

hepatotoxicity, " said Dr. Benson. " For liver disease patients who don't want to

risk the side effects of NSAIDs, acetaminophen is a superior pain management

choice. "

Acetaminophen is a commonly used analgesic/antipyretic that is recommended for

management of mild-to-moderate pain and fever. It has been available without a

prescription for almost 50 years in the United States.5 It is widely accepted

that acetaminophen is safe and well tolerated at recommended doses. Its

analgesic and antipyretic efficacies are generally considered equivalent to

those of aspirin.6

About McNeil Consumer & Specialty Pharmaceuticals

McNeil Consumer & Specialty Pharmaceuticals, a division of McNeil-PPC, Inc.,

markets prescription and over-the-counter (OTC) pharmaceutical products. The

company's OTC products include complete lines of TYLENOL® (acetaminophen), which

celebrates 50 years of trust and innovation in 2005, and MOTRIN® IB (ibuprofen)

for adults and children. Prescription products include CONCERTA®

(methylphenidate HCl) extended-release tablets and FLEXERIL® (cyclobenzaprine

HCl) 5 mg tablets. Other McNeil Consumer & Specialty Pharmaceuticals brands

include IMODIUM® A-D (loperamide HCI and simethicone) anti-diarrheal, ST.

JOSEPH® 81 mg Adult Aspirin and NIZORAL® (ketoconazole) A-D Shampoo.

1 Benson GD, Koff RS, Tolman KG. Therapeutic use of acetaminophen in patients

with liver disease. Am J Ther. 2005; 12(2): 133-141.

2 Benson GD. Acetaminophen in chronic liver disease. Clin Pharmacol Ther.

1983;33:95-101.

3 Dargere S, Collet T, Crampon D, et al. Lack of toxicity of acetaminophen in

patients with chronic hepatitis C: a randomized controlled trial.

Gastroenterology. 2000;118:A947.

4 Benson GD. Acetaminophen in chronic liver disease. Clin Pharmacol Ther.

1983;33:95-101.

5 Prescott LF. Paracetamol: past, present and future. Am J Ther. 2000;

7:143-147.

6 Benson GD, Koff RS, Tolman KG. Therapeutic use of acetaminophen in patients

with liver disease. Am J Ther. 2005; 12(2): 133-141.

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