Lamictal (lamotrigine) is a prescription medication that's 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 simple 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 danger of aseptic meningitis from Lamictal. This rare but potentially life-threatening side-effect occurs when the meninges (protective membrane covering the mind 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 1 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 can be a generalized drug reaction or hypersensitivity.
Lamictal Stevens-Johnson Syndrome
The Warnings & Precautions for Lamictal features a prominent Black Box Warning about the chance of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). These severe rashes are estimated to affect one in 1,000 adults and as much as 1 in 50 children.
SJS and TEN cause the epidermis (top layer of skin) to blister and peel from the lime in large sheets. These rashes are really disfiguring, painful, and typically should be treated with intensive care. They could also cause life-threatening infections or other complications. Many cases of Stevens-Johnson Syndrome from Lamictal occurred within 2-8 weeks of treatment, although rare cases have occurred around 6 months later.
Doctors should discontinue patients on Lamictal at the first sign of a rash unless the rash is clearly not due to Lamictal.