FDA Revises Warning Label of Lamictal by GlaxoSmithKline

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The US Food and Drug Administration (FDA) is revising the Warnings and Precautions section of lamotrigine (Lamictal) by GlaxoSmithKline. The drug has been associated with 40 cases of aseptic meningitis.

Aseptic meningitis, also called sterile meningitis, is an illness similar to bacterial meningitis, however bacteria do not grow in cultures of cerebrospinal fluid (CSF). The condition is usually caused by one of several viruses, including enterovirus, varicella, or herpes.

Lamictal is approved for the treatment of epilepsy in children 2 years and older, and for treating bipolar disorder in adults. The drug is sold as an orally disintegrating tablet (Lamictal ODT), a chewable tablet (Lamictal CD), and as an extended release medication (Lamictal XR). It is estimated that more than 46 million prescriptions have been dispensed since its initial approval.

The FDA reviewed adverse event reports submitted between December 1994 and November 2009. A total of 40 cases of aseptic meningitis were identified in both pediatric and adult patients taking the drug. Among those, headache, fever, nausea, vomiting, nuchal rigidity (neck stiffness), rash, photophobia, and myalgias were the most common symptoms, occurring one to 42 days after initiation of lamotrigine.

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Thirty-five of the 40 patients required hospitalization. CSF analysis showed mild to moderate pleocytosis (increased cell count), normal glucose levels, and mild to moderate increase in protein in 25 cases.

Some of the treated patients had underlying diagnoses of systemic lupus erthematosus or other autoimmune diseases. Some patients developed abnormalities in the liver and kidneys, possibly indicating a hypersensitivity or generalized drug reaction.

In most cases, symptoms resolved after lamotrigine was withdrawn, but 15 reported a rapid return of symptoms (within 30 minutes to 24 hours) when Lamictal was reinstated.

“Aseptic meningitis is a rare but serious side effect of Lamictal use,” said Russell Katz MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. Healthcare professionals are advised that if meningitis is suspected, “discontinuation of Lamictal should be considered if no other clear cause of meningitis is identified.”

Patients who experience adverse events related to lamotrigine should first contact their healthcare provider for treatment. To file a report with the FDA regarding this or any other drug event, contact MedWatch by telephone at 1-800-1088, by fax at 1-800-FDA-0178, MedWatch Online; or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20857 (use postage-paid FDA Form 3500).

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