Clinical Toxicology (2008) 46, 496–500
Copyright © Informa Healthcare USA, Inc.
ISSN: 1556-3650 print / 1556-9519 online
DOI: 10.1080/15563650701864760
LCLT
ARTICLE
Lower incidence of anaphylactoid reactions to
N-acetylcysteine in patients with high acetaminophen
concentrations after overdose
Anaphylactoid reactions to NAC
W. STEPHEN WARING, ALEXANDRA F. STEPHEN, OLIVER D. ROBINSON,
MARGARET A. DOW, and JANICE M. PETTIE
Scottish Poisons Information Bureau, The Royal Infirmary of Edinburgh, Edinburgh, United Kingdom
Background. Mechanisms responsible for anaphylactoid reactions to N-acetylcysteine (NAC) are poorly understood, and
acetaminophen itself may play an important role. The present study examined the relationship between serum acetaminophen
concentrations and risk of anaphylactoid reactions. Methods. Prospective study of adverse reactions to NAC administered according
to standardized clinical protocols in patients who present to hospital after acute acetaminophen overdose. Subgroups were defined by
serum acetaminophen concentrations 0 to 100 mg/L, 101 to 150 mg/L, 151 to 200 mg/L, 201 to 300 mg/L, and >300 mg/L. Results. There
were 362 patients, and anaphylactoid reactions occurred in 14.9%. Anaphylactoid reactions occurred less commonly in patients with
high serum acetaminophen concentrations (p = 0.046 by Cochran-Armitage trend test) and high equivalent 4 h acetaminophen
concentrations (p = 0.004). Discussion. High serum acetaminophen concentrations were associated with fewer anaphylactoid
reactions, suggesting that these might in some way be protective. The biological basis needs further exploration so as to allow a better
understanding of the mechanisms responsible for adverse reactions to NAC treatment.
Keywords Acetaminophen; Adverse drug reaction; Overdose; Poisoning; Toxicity
Introduction
N-acetylcysteine (NAC) minimizes the risk of hepatotoxicity
after acute acetaminophen overdose. However, a high propor-
tion of patients experience adverse reactions to NAC, which
are variably reported to occur in 5–15% of patients in retro-
spective studies, and 40–56% in prospective studies [1–5].
Anaphylactoid reactions to NAC are characterized by
erythema, urticaria, flushing, brochospasm, wheeze, and
hypotension [6,7]. Around 15–30% of patients develop a dif-
fuse erythematous or urticarial rash, which typically affects
the upper trunk, neck, and face [8,9]. While the clinical pre-
sentation is similar to true anaphylaxis, anaphylactoid reac-
tions differ because prior exposure to NAC is not required,
and treatment can normally be reintroduced without provok-
ing a further reaction [7]. Features typically occur 20–60 min
after commencing intravenous NAC, and subside quickly
after the infusion is stopped [10]. Onset coincides with
expected peak serum NAC concentrations during the standard
intravenous loading regimen [11], and inadvertent adminis-
tration of very high dosages is associated with severe anaphy-
lactoid reactions [10]. Localized wheal and flare responses to
NAC are concentration-dependent [12]. The incidence of
anaphylactoid reactions may be reduced when the initial
loading dose of NAC 150 mg/kg is administered over 60 or
90 min instead of the standard 15 min regimen [5, 13, 14].
For example, adverse reactions occurred in 49 of 109 (45%)
after 15 min infusion, versus 27 of 71 (38%) after 60 min
infusion, although the difference was not statistically
significant [13].
Existing data suggest that anaphylactoid reactions are
directly related to serum concentrations of NAC, and that risk
is dose-dependent [5,13,14]. Nonetheless, the basic biologi-
cal mechanisms of anaphylactoid reactions remain unclear.
Histamine appears to be an important mediator, and wheal
responses to localized NAC can be abolished by prior treat-
ment with a selective histamine-1 receptor antagonist [12].
NAC is also capable of evoking endothelium-independent
vasodilatation, possibly due to a direct relaxant effect on vas-
cular smooth muscle [15]. Preliminary clinical data indicate
fewer anaphylactoid reactions in patients with high serum
acetaminophen concentrations, suggesting that acetami-
nophen itself might be capable of conferring protective
Received 16 August 2007; accepted 12 December 2007.
Address correspondence to William Stephen Waring, Ph.D.,
F.R.C.P., The Royal Infirmary of Edinburgh, Scottish Poisons
Information Bureau, 51 Little France Crescent, Edinburgh, EH16
4SA United Kingdom. E-mail: s.waring@ed.ac.uk
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