The tolerability of lamotrigine in children

Lamotrigine is a novel anticonvulsant, which has proven to be effective bot h 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 the rapies. Generally, lamotrigine treatment in these clinical trials was gener ally given at higher initial doses and faster dose escalations than are cur rently recommended. Most adverse events associated with lamotrigine were mild to moderate in se verity and did not result in discontinuation of treatment. Results from pla cebo-controlled, add-on trials showed that 85% of lamotrigine recipients ex perienced an adverse event compared with 83% of placebo recipients. Lamotri gine 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 event s was lower among lamotrigine recipients in monotherapy trials than in add- on trials, suggesting that concurrent anticonvulsant treatment or drug inte ractions can be confounding risk factors above that of lamotrigine treatmen t alone. Skin rash associated with hospitalisation and the discontinuation of study drug was reported more frequently by lamotrigine recipients than b y placebo recipients and more frequently by children than by adults. The si multaneous use of valproic acid (sodium valproate) was associated with an i ncreased incidence of rash. Lamotrigine, an effective broad spectrum anticonvulsant, is well tolerated in children. The qualitative features of adverse events that occur with lam otrigine treatment are similar for children and adults. The incidence of ra sh may be reduced with proper initial dosing and dose escalation.