Without knowledge of the risk associated with the initiation of alternative anticonvulsant therapies, the benefit-risk assessment for lamotrigine was not definable. National registries had published rates of SJS and toxic epidermal necrolysis (TEN) associated with alternative therapies. However, these estimates were based on total defined daily doses in the denominator (Roujeau et al., 1990; Schopf et al., 1991). Given that the at-risk period was likely to be limited to the first few weeks, it seemed likely that denominators based on the total population exposed to an individual therapy would underestimate those at risk by using a denominator which was too large. Therefore, several retrospective cohort studies were initiated to measure the risk of serious cutaneous reactions in new users of older alternative antiepileptic medications associated with serious cutaneous reactions.
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