Multicenter, randomized, double-blind, active-controlled, parallel-group trial of the long-term (6–12 months) safety of acetaminophen in adult patients with osteoarthritis*
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Cited by (74)
A critical review of the acetaminophen preclinical carcinogenicity and tumor promotion data and their implications for its carcinogenic hazard potential
2020, Regulatory Toxicology and PharmacologyApplication of the DILIsym® Quantitative Systems Toxicology drug-induced liver injury model to evaluate the carcinogenic hazard potential of acetaminophen
2020, Regulatory Toxicology and PharmacologyAcetaminophen (APAP or N-Acetyl-p-Aminophenol) and Acute Liver Failure
2018, Clinics in Liver DiseaseCitation Excerpt :A lower threshold (4–10 g) for evaluation may be considered in a high-risk population, such as those with excess alcohol intake. Although most studies have reported safety of short-term and long-term use of APAP at the maximum recommended dose of 4 g,46,47 a well-designed, randomized placebo-controlled study of 145 healthy volunteers reported that the daily intake of APAP of 4 g for 14 days was associated with asymptomatic elevations of alanine aminotransferase (ALT) (>3 times the upper limits of normal) in up to 40% of subjects.48 These elevations of ALT occurred despite APAP concentrations being within therapeutic limits, and resolved after APAP discontinuation without any clinical consequences.48
Acetaminophen-related Hepatotoxicity
2013, Clinics in Liver DiseaseCitation Excerpt :A lower threshold (4–10 g) for evaluation may be considered in a high-risk population (discussed later). Although most studies have reported safety of short-term and long-term use of APAP at the maximum recommended dose of 4 g,23,24 a well-designed, randomized placebo-controlled study of 145 healthy volunteers reported that the daily intake of APAP of 4 g for 14 days was associated with asymptomatic elevations of alanine aminotransferase (ALT) (>3 times the upper limits of normal) in up to 40% of subjects.25 These elevations of ALT occurred despite APAP concentrations being within therapeutic limits, and resolved after APAP discontinuation, and without any clinical consequences.25
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This work was presented in part at the OsteoArthritis Research Society International (OARSI) 9th World Congress, December 2–5, 2004, Chicago. The abstract submitted to the meeting was published in Osteoarthritis Cartilage, 2004; 12B:84S.
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Current affiliation: Consultant to McNeil Consumer & Specialty Pharmaceuticals.