Rash in Multicenter Trials of Lamotrigine in Mood Disorders: Clinical Relevance and Management
J Clin Psychiatry 2002;63(11):1012-1019
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Background: The rate of lamotrigine-associated
rash in patients with mood disorders has not been well
characterized. The objective of this report was to determine rash
rates in clinical trials of lamotrigine in DSM-IV unipolar
depression or bipolar disorder.
Method: A retrospective analysis was conducted
of rates of lamotrigine-related rash in 12 multicenter studies,
including 1 open study, 7 randomized controlled acute trials, and
4 randomized controlled maintenance trials from 1996 to 2001.
Results: A total of 1955 patients were treated
with lamotrigine in open-label settings (open-label phases
preceding or following randomization and 1 stand-alone open-label
study); 1198 patients received lamotrigine in controlled
settings, and 1056 patients received placebo. In controlled
settings, rates of benign rash were 8.3% and 6.4% in lamotrigine-
and placebo-treated patients, respectively. Rates of serious rash
were 0% with lamotrigine, 0.1% (N = 1) with placebo, and 0% with
comparators. In the open-label setting, the overall rate of rash
for lamotrigine was 13.1% (N = 257) and of serious rash, 0.1% (N
= 2). One mild case of Stevens-Johnson syndrome not requiring
hospitalization occurred in a patient treated with lamotrigine.
There were no cases of toxic epidermal necrolysis in any setting.
Conclusion: Serious drug eruptions associated
with lamotrigine were rare. Although rash is a potentially
life-threatening reaction, the risk of serious rash due to
lamotrigine should be weighed against more common risks
associated with untreated or undertreated bipolar depression.