The tolerability of lamotrigine in children.

Lamotrigine is a novel anticonvulsant, which has proven to be effective both as add-on and monotherapy. 13 studies have demonstrated efficacy in 1096 children with a variety of seizure types. Tolerability information in these studies was collected in a standard fashion, where investigators reported all adverse events regardless of the perceived relationship to the test therapies. Generally, lamotrigine treatment in these clinical trials was generally given at higher initial doses and faster dose escalations than are currently recommended. Most adverse events associated with lamotrigine were mild to moderate in severity and did not result in discontinuation of treatment. Results from placebo-controlled, add-on trials showed that 85% of lamotrigine recipients experienced an adverse event compared with 83% of placebo recipients. Lamotrigine was associated with an increased risk of adverse events in the nervous system (dizziness, tremor, ataxia, and diplopia), gastrointestinal tract (nausea), and urinary tract (infection). The incidence of most adverse events was lower among lamotrigine recipients in monotherapy trials than in add-on trials, suggesting that concurrent anticonvulsant treatment or drug interactions can be confounding risk factors above that of lamotrigine treatment alone. Skin rash associated with hospitalisation and the discontinuation of study drug was reported more frequently by lamotrigine recipients than by placebo recipients and more frequently by children than by adults. The simultaneous use of valproic acid (sodium valproate) was associated with an increased incidence of rash. Lamotrigine, an effective broad spectrum anticonvulsant, is well tolerated in children. The qualitative features of adverse events that occur with lamotrigine treatment are similar for children and adults. The incidence of rash may be reduced with proper initial dosing and dose escalation.