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  • FDA Date: 08/12/2010

    Lamictal XR (lamotrigine extended-release) FDA Drug Safety Communication

    Aseptic Meningitis Associated with Use of Lamictal (lamotrigine)

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    FDA is informing the public that Lamictal (lamotrigine), a medication commonly used for seizures in children two years and older, and bipolar disorder in adults, can cause aseptic meningitis. FDA is revising the Warnings and Precautions section of the drug label and the patient Medication Guide to include information about this risk.

    Meningitis is an inflammation of the protective membranes (the meninges) that cover the brain and spinal cord. Aseptic meningitis is generally diagnosed when tests of a patient with signs and symptoms of meningitis do not detect bacteria. Causes of aseptic meningitis include viruses and other non-bacterial infections, toxic agents, some vaccines, malignancy, and certain medications, including Lamictal. Symptoms 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.

    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.

    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).

    View the full FDA Drug Safety Communication on FDA.gov