BACKGROUND ON LAMICTAL
Lamictal is approved for maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy. The effectiveness of Lamictal in the acute treatment of mood episodes has not been established. A prospectively defined combined analysis revealed significant benefits for Lamictal over placebo for delaying both time to intervention for mania (P=0.034) and depression (P=0.009) - the finding in depression was more robust (see Indication section in Prescribing Information).
Lamictal is also indicated as adjunctive therapy for adult and pediatric (greater than or equal to 2 years of age or older) patients with epilepsy who have partial seizures and for the generalized seizures of Lennox-Gastaut syndrome in adult and pediatric patients (greater than or equal to 2 years of age or older). Lamictal is also indicated for conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme- inducing AED and, more recently, in patients converting from valproate.
The safety and effectiveness of Lamictal have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from non-enzyme-inducing anti epileptic drugs (except for valproate), or 3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. Safety and effectiveness in patients below the age of 16 other than those with partial seizures and the generalized seizures of Lennox-Gastaut syndrome have not been established.
Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of Lamictal. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients under the age of 16 years receiving Lamictal as adjunctive therapy for epilepsy, and 0.3% (3 per 1,000) in adults on adjunctive therapy for epilepsy. In mood and bipolar disorder clinical trials, the rate of serious rash was 0.08% of adult patients who received Lamictal as initial monotherapy and 0.13% of adult patients who received
Lamictal as adjunctive therapy. In a prospectively followed cohort of 1,983 pediatric patients taking adjunctive Lamictal, there was one rash-related death. In worldwide post-marketing experience, rare cases of toxic epidermal necrolysis (TEN) and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate.
Because the rate of serious rash is greater in pediatric patients than in adults, it bears emphasis that Lamictal is approved only for use in pediatric patients below the age of 16 years who have partial seizures or seizures associated with the Lennox-Gastaut syndrome (see Indications Section in Prescribing Information).
Other than age, there are as yet no factors identified that are known to predict the risk of occurrence or the severity of rash associated with Lamictal. There are suggestions, yet to be proven, that the risk of rash may also be increased by co-administration of Lamictal with valproate, exceeding the recommended initial dose of Lamictal, or exceeding the recommended dose escalation for Lamictal. However, cases have been reported in the absence of these factors. Lamictal should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related.
- GlaxoSmithKline
Articles in The Science of Mental Health are written by the originating institution. This article summarizes research presented to the American Psychiatric Association in May of 2004.
