Can cause serious and potentially life-threatening rash, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and/or rash-related death. (See Dermatologic Reactions under Cautions.)
Risk of serious rash is greater in pediatric patients than in adults (see Pediatric Use under Cautions) and may be increased by concomitant use of valproic acid (valproate, divalproex sodium) or by exceeding the recommended initial dosage or dosage escalation schedule for lamotrigine.
Cases of life-threatening rash associated with immediate-release lamotrigine almost always have occurred within 2–8 weeks of treatment initiation; however, isolated cases have been reported following prolonged treatment (e.g., 6 months).
Can also cause benign rashes; however, it is not possible to predict which rashes will become serious or life-threatening. Discontinue therapy at the first sign of rash (unless the rash is clearly not drug related).
Discontinuance of therapy may not prevent rash from becoming life-threatening or permanently disabling or disfiguring.
REMS:
FDA approved a REMS for lamotrigine to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
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