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Safety and efficacy of intravenous N‐acetylcysteine for acetaminophen overdose: analysis of the Hunter Area Toxicology Service (HATS) database

ABSTRACT Background: Acetaminophen (N‐acetyl-p‐aminophenyl; APAP) is the leading drug used in self-poisoning and frequently causes hepatotoxicity, including acute liver failure. Objective: To provide descriptive data on the safety and efficacy of intravenous N‐acetylcysteine (IV‐NAC) in the treatment of APAP toxicity, based on information in the Hunter Area Toxicology Service (HATS) database involving residents of the Greater Newcastle Area of New South Wales, Australia. Methods: This was a retrospective analysis of all APAP overdoses from January 1987 to January 2003. Data were collected prospectively according to a published protocol and included patient characteristics, exposures to APAP and other potential toxins, treatments, and outcomes. Primary safety/tolerability endpoints included the mortality rate and incidence of adverse drug reactions, while efficacy endpoints included alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels. Results: Of 1749 patients, 399 (22.8%) were treated with IV‐NAC. Of these, 37 (9.3%) had an adverse drug reaction to IV‐NAC, of which seven (1.8% of total) were anaphylactoid. There were five deaths in hospital (mortality rate = 0.3%), including two attributed to APAP (0.1%) and none to IV‐NAC. Of 64 patients who were treated with IV‐NAC within 8 hours after APAP ingestion and had available ALT/AST data, two (3.1%) developed hepatotoxicity (AST/ALT > 1000 IU/L) compared with 32 (25%) of 128 patients receiving IV‐NAC > 8 hours after APAP ingestion ( p = 0.0002). A total of 26 patients (15.6%) receiving IV‐NAC treatment within 8 hours after APAP ingestion had hospitalization stays > 48 hours compared with 70 (33.3%) receiving IV‐NAC > 8 hours after ingestion ( p < 0.0001). Conclusions: For patients with APAP overdose seen in the HATS database of New South Wales, Australia, in-hospital death was infrequent (< 1%) and hepatotoxicity was significantly less likely when IV‐NAC was administered within 8 hours after APAP ingestion compared with longer intervals ( p < 0.01). As a descriptive retrospective database analysis, this study could not exclude certain sources of bias, including temporal changes over the 16‐year course of data collection in the use of IV‐NAC and low ascertainment of mild, self-limiting reactions to IV‐NAC.