Tender Is the Night

WHAT IS LAMICTAL?

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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 rash, 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.