The Food and Drug Administration (FDA) has issued a safety warning that lamotrigine (Lamictal™), a medication commonly used for seizures in children 2 years of age and older, and bipolar disorder in adults, can cause aseptic meningitis. Lamictal is also sold as an orally disintegrating tablet (Lamictal ODT), a chewable, dispersible tablet (Lamictal CD), and as an extended release product (Lamictal XR).

The FDA is revising the Warnings and Precautions section of the drug label and the patient Medication Guide to include information about the risk of aseptic meningitis.

Aseptic meningitis is a nonbacterial inflammation of the protective membranes that cover the brain and spinal cord. Causes of aseptic meningitis include viruses and other nonbacterial infections, toxic agents, some vaccines, malignancy, and certain medications. Symptoms of meningitis may include headache, fever, stiff neck, nausea, vomiting, rash, and sensitivity to light. In cases of meningitis, it is important to rapidly diagnose the underlying cause so that treatment can be promptly initiated.

The decision to revise the Lamictal label is based on FDA’s identification of 40 cases of aseptic meningitis in patients taking Lamictal from December 1994 to November 2009. During this same time period, it is estimated that more than 46 million prescriptions for Lamictal were dispensed. In most cases, the symptoms were reported to have resolved after Lamictal was discontinued. In 15 cases, the symptoms returned when patients restarted Lamictal.

Healthcare professionals should be aware that Lamictal can cause aseptic meningitis. If meningitis is suspected, patients should also be evaluated for other causes of meningitis and treated as indicated. Discontinuation of Lamictal should be considered if no other clear cause of meningitis is identified.

Patients who take Lamictal and experience headache, fever, chills, nausea, vomiting, stiff neck, rash, abnormal sensitivity to light, drowsiness, or confusion should contact their healthcare professional right away.

1. Food and Drug Administration (FDA). Drugs. FDA Drug Safety Communication: Aseptic meningitis associated with use of Lamictal (lamotrigine). August 12, 2010. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm221847.htm. Accessed August 13, 2010.

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This entry was posted on Friday, August 13th, 2010 at 12:00 pm.