A multicenter comparison of the safety of oral versus intravenous acetylcysteine for treatment of acetaminophen overdose

Abstract

Oral and intravenous (IV) N-acetylcysteine (NAC) are used for the treatment of acetaminophen poisoning. The objective of this multicenter study was to compare the safety of these two routes of administration. Methods. We conducted a multicenter chart review of all patients treated with NAC for acetaminophen poisoning. The primary safety outcome was the percentage of patients with NAC-related adverse events. Results. A total of 503 subjects were included in the safety analysis (306 IV-only, 145 oral-only, and 52 both routes). There were no serious adverse events related to NAC for either route. Nausea and vomiting were the most common related adverse events and were more common with oral treatment (23 vs. 9%). Anaphylactoid reactions were more common with IV administration (6 vs. 2%). Conclusions. IV and oral NAC are generally mild adverse drug reactions.

Keywords:

• Acetaminophen
• N-Acetylcysteine
• Acute poisoning

Acknowledgment

This project was supported by the 2004 American College of Clinical Toxicology Multi-Center Research Grant and an unrestricted research grant from Cumberland Pharmaceuticals. Rocky Mountain Poison and Drug Center (RMPDC) was the coordinating center for this multi-center study. All funds were paid out to the participating centers and RMPDC received no support for this project. RMPDC has clinical, consulting, and research contracts with Cumberland Pharmaceuticals (a manufacturer of IV acetylcysteine) and McNeil Consumer Healthcare (a manufacturer of acetaminophen products). The investigators were responsible for the design, performance, and analysis of the study and for the drafting and revisions of the manuscript. The sponsors had no role in the study design, performance, and did not review the manuscript prior to acceptance. Dr. Heard was supported by Award Number K08DA020573 from the National Institute on Drug Abuse. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute on Drug Abuse or the National Institutes of Health.

Declaration of interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this paper.

Notes

*Wilford Hall Medical Center: Vikhyat S. Bebarta; Indiana University School of Medicine: Louise Kao, Blake Froberg; UCSD Medical Center: Richard F. Clark; Carolinas Medical Center: Eric Lavonas, Ming Qi; Hartford Hospital: Joao Delgado, John McDonagh; LSU Health Sciences Center: Tom Arnold; New York City Poison Center: Oladapo Odujebe; Albert Einstein Medical Center: Gerry O'Malley, Claudia Lares, Elizabeth Aguilera; Denver Health-Rocky Mountain Poison Center: Richard Dart MD, PhD, Kennon Heard MD, Chriss Stanford MA, Jamie Kokko MPH, Greg Bogdan PhD, Carrie Mendoza MD, Sara Mlynarchek MPH, Sean Rhyee MD, Jason Hoppe DO, William Haur MD , Hock Heck Tan MD, Nguyen Nguyen Tran MD, Shawn Varney MD, Amy Zosel MD, Jennifer Buchanan MD, Mohammed Al-Helial MD.