In some patients, rash progresses to a systemic illness with fever, arthralgia, myalgia, lymphadenopathy, eosinophilia, and malaise. Erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis occur rarely. Based upon clinical trials and post-marketing reports, the risk of severe dermatologic reaction is 0.3% in adults and approximately 1% in children 16 years and younger.

The risk factors for severe dermatologic reactions with Lamictal include:

• younger age (children more than adults)
• co-medication with valproate
• a rapid rate of Lamictal titration
• high Lamictal starting dose

Any rash should be evaluated promptly. It is generally recommended that Lamictal be discontinued at the first sign of rash, unless the rash is clearly not drug-related.

On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3.5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA's data at its meeting on July 10. The FDA has provided the following information for patients, family members, and caregivers at www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.

• Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions;
• Do not make any changes to the medication regimen without first talking with the responsible healthcare professional;
• Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
• Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
  • Talking or thinking about wanting to hurt yourself or end your life
  • Withdrawing from friends and family
  • Becoming depressed or having your depression get worse
  • Becoming preoccupied with death and dying
  • Giving away prized possessions

We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood.

Reviewed July 2008 by Steven C. Schachter, MD, epilepsy.com Editorial Board.