Safety Alerts & Recalls

What does this mean?

Although aseptic meningitis is a serious side effect of Lamictal, it is quite rare and symptoms usually improve or go away when the medicine is stopped. The benefits of this medicine will continue to outweigh the risks for most people. Please read the Medication Guide given to you each time you are dispensed your Lamictal. It will explain the risks and benefits of Lamictal. If you have any concerns about your benefits or risks from Lamictal, please discuss them with your doctor or other healthcare professional.

Please contact your healthcare professional right away if you experience headache, fever, chills, nausea, vomiting, stiff neck, rash, abnormal sensitivity to light, drowsiness, or confusion while taking Lamictal. These could be early signs of aseptic meningitis.

You can report any side effects from the use of Lamictal or any other medicine to the FDA MedWatch program by phone at 1-800-332-1088; by fax at 1-800-332-0178; by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch website at www.fda.gov/medwatch

FDA: Aseptic Meningitis Risk with Use of Seizure Drug Lamictal

The U.S. Food and Drug Administration (FDA) has issued a warning that the drug Lamictal (lamotrigine) can cause aseptic meningitis, an inflammation of the protective membranes (meninges) that cover the brain and spinal cord not caused by bacterial infection. Aseptic meningitis has a number of causes including, but not limited to, viruses, toxic agents, some vaccines, autoimmune diseases, and certain medications, including Lamictal. Symptoms can include headache, fever, chills, nausea, vomiting, stiff neck and sensitivity to light. Hospitalization may be required for some patients with aseptic meningitis. The drug's manufacturer, GlaxoSmithKline, will work with the FDA to update the prescribing information and patient medication guide for Lamictal to include this risk.

Lamictal is approved to treat seizures and bipolar disorder. Lamictal contains the active ingredient lamotrigine and is also sold as an orally disintegrating tablet (Lamictal ODT), a chewable, dispersible tablet (Lamictal CD), and as an extended release product (Lamictal XR).

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Source: FDA
Publication Date: 2010-08-12
Last Updated: 2010-08-13

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