Unintentional hepatotoxicity due to acetaminophen use at the recommended daily dose of up to four grams daily has increasingly been recognized as a significant problem. The phrase "therapeutic misadventure" has been coined in the literature, in reference to biochemical evidence of hepatocellular injury associated with acetaminophen use at recommended doses. Previous studies have documented a 25% to 40% incidence of two- to three-fold alanie aminotransferase (ALT) elevation, in healty volunteers administered one gram of acetaminophen every six hours.
The recognition of this problem is reflected in part by recent changes in FDA recommendations, including more stringent controls on the amount of acetaminophen which may be contained per tablet in combination formulations together with narcotics. Furthermore, an advisory panel to the FDA recommended that the currently widely accepted maximum daily dose of up to four grams daily may be too high.
Recommended CitationCivan, Jesse; Navarro, Victor; Riggio, Jeffrey; Adams, Paul; Herrine, Steven; and Rossi, Simona, "Patterns of Acetaminophen Use at a Tertiary Care Center: Exposures Exceeding 4 Grams Daily" (2012). Jefferson Hospital Staff Papers and Presentations. Paper 10.