Data from clinical trials with lamotrigine indicate that the risk of s
erious rash in pediatric patients is higher than in adults. The incide
nce of rash associated with hospitalization among adults treated with
lamotrigine is 0.3% and among pediatric patients 1.0%. The incidence o
f cases reported as possible Stevens-Johnson syndrome is 0.1% for adul
t patients and 0.5% for pediatric patients. These rates reflect lamotr
igine dosing and concomitant AEDs used in these trials, both of which
are risk factors for rash. Since many of the trials were conducted pri
or to the establishment of the current dosing recommendations, the inc
idence of serious rash in clinical trials does not necessarily reflect
the incidence to be expected with use of current dosing recommendatio
ns. The higher incidence of serious rash in pediatric patients may at
least partially be accounted for by the differential effects of the ri
sk factors of dosing and concomitant use of valproic acid in these pat
ients.