The anti-seizure drug Lamictal (lamotrigine) carries a Boxed Warning about the risk of life-threatening skin reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. The FDA has also issued warnings for aseptic meningitis, suicidal behavior, and birth defects (cleft lip and/or cleft palate) in patients who were taking Lamictal.

What is Lamictal?

Lamictal (lamotrigine) is a prescription medication that is used to prevent seizures in people with epilepsy. It was approved by the FDA in 1994 and is sold by GlaxoSmithKline (GSK). Lamictal is now available as a generic drug. There are several versions, including extended-release (Lamictal XR), an orally-disintegrating tablet (Lamictal ODT), and a chewable tablet (Lamictal CD).

FDA Safety Alert for Lamictal and Aseptic Meningitis

In August 2010, the U.S. Food and Drug Administration (FDA) issued a Safety Alert about the risk of aseptic meningitis from Lamictal. This rare but potentially life-threatening side effect occurs when the meninges (protective membrane covering the brain and spinal cord) becomes inflamed.

Lamictal Side Effects

Lamictal was associated with a total of 40 cases of aseptic meningitis between December 1994 and November 2009. Symptoms occurred as soon as one day after starting Lamictal, but within an average of 16 days. One patient died and 35 were hospitalized. When doctors re-started patients on Lamictal, 15 developed severe symptoms within 30 minutes to 24 hours. These symptoms suggest that the reactions may be a generalized drug reaction or hypersensitivity.

Symptoms of Aseptic Meningitis from Lamictal

  • Headache
  • Fever
  • Stiff neck
  • Nausea, vomiting
  • Rash
  • Sensitivity to light
  • Drowsiness
  • Confusion.

Lamictal Stevens-Johnson Syndrome

The Warnings & Precautions for Lamictal includes a prominent Black Box Warning about the risk of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). These severe rashes are estimated to affect one in 1,000 adults and up to 1 in 50 children.

SJS and TEN cause the epidermis (top layer of skin) to blister and peel off in large sheets. These rashes are extremely disfiguring, painful, and almost always must be treated with intensive care. They can also lead to life-threatening infections or other complications.

Most cases of Stevens-Johnson Syndrome from Lamictal occurred within 2-8 weeks of treatment, although rare cases have occurred up to 6 months later.

Doctors should discontinue patients on Lamictal at the first sign of a rash unless the rash is clearly not caused by Lamictal.

Lamictal Side Effects

  • Rash
  • Stevens-Johnson Syndrome
  • Toxic Epidermal Necrolysis
  • Hypersensitivity reactions
  • Blood disease (neutropenia, thrombocytopenia, pancytopenia)
  • Suicidal behavior and ideation
  • Aseptic meningitis
  • Birth defects (cleft lip and/or cleft palate)
  • Dizziness
  • Headache
  • And more.

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