Serious Skin Rashes

Cases of life-threatening serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and/or rash-related death have been caused by lamotrigine. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include:

• coadministration with valproate.
• exceeding recommended initial dose of LAMICTAL.
• exceeding recommended dose escalation for LAMICTAL.
• presence of the HLA-B*1502 allele. (5.1)

Benign rashes are also caused by lamotrigine; however, it is not possible to predict which rashes will prove to be serious or life threatening. LAMICTAL should be discontinued at the first sign of rash, unless the rash is clearly not drug related. (5.1)