Guidelines and Studies
Clinical Resources on Acetaminophen Efficacy and Safety
Printable materials and useful Web links
McNeil Consumer Healthcare is pleased to make these resources available to you. Return often; new materials will continue to be added.
Web Resources
The resources below will link you to guidelines that have recommended acetaminophen as first-line therapy for mild-to-moderate osteoarthritis pain:
American College of Rheumatology*
American Academy of Orthopaedic Surgeons
*The American College of Rheumatology is an independent professional, medical, and scientific society that does not guarantee, warrant, or endorse any commercial product or service.
Independent Clinical Studies
Efficacy
Comparison of an anti-inflammatory dose of ibuprofen, an analgesic dose of ibuprofen, and acetaminophen in the treatment of patients with osteoarthritis of the knee. Bradley JD, Brandt KD, Katz BP et al.
View PDFEfficacy of rofecoxib, celecoxib, and acetaminophen in osteoarthritis of the knee. Geba GP, Weaver AL, Polis AB, et al.
View PDFClinical Studies
Safety
Multicenter, randomized, double-blind, active-controlled, parallel-group trial of the long-term (6-12 months) safety of acetaminophen in adult patients with osteoarthritis. Temple AR, Benson GD, Zinsenheim JR and Schweinle JE.
View PDFAminotransferase activities in healthy subjects receiving three-day dosing of 4, 6, or 8 grams per day of acetaminophen. Temple AR, Lynch JM, Vena JV et al.
Acetaminophen is a widely used analgesic-antipyretic and considered one of the safest of the available pain relievers(1,2). One report from the United States indicates that 23% of adults may have used an acetaminophen-containing medication during the week prior to the survey (1). The approved daily dose is 1000 mg (1 g) given every 4 to 6 hours up to a total of 4000 mg (4 g) per day (3). A review of the literature indicates that only two prospective controlled trials have reported multiple administration of doses above this level (4,5). While conducting the present study to determine the disposition and tolerability of acetaminophen at and above 4 g/d (6), aminotransferase activities were determined at least daily in subjects while over 3 days and during baseline and washout periods. Clinical signs, symptoms, and daily aspartate aminotransferase (AST) and alanine aminotransferase (ALT) determinations were used to assess tolerability and hepatic safety. Acetaminophen and its metabolites were measured in plasma and urine to characterize the disposition of higher acetaminophen doses over 3 days of continuous consumption. The purpose of this article is to report the results of daily aminotransferase activities and acetaminophen-related metabolic parameters. Pharmacokinetic results of this study have been described elsewhere (6).
View full article at Informaworld.com
Retrospective analysis of transient elevations of alanine aminotransferase during long-term treatment with acetaminophen in osteoarthritis clinical trials. Kuffner EK, Temple AR, Cooper KM et al.
View PDFThe therapeutic use of acetaminophen in patients with liver disease. Benson GD, Koff RS and Tolman KG.
View PDFEffect of maximal daily doses of acetaminophen on the liver of alcoholic patients. Kuffner EK, Dart RC, Bogdan GM et al.
View PDFProfessional Product Information from McNeil Consumer Healthcare
Tylenol® Professional Product Monograph
View PDFOverdose Management
Guidelines for the Management of Acetaminophen Overdose
View PDFNomogram for acute acetaminophen overdose
View PDF
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