FDA Warns of Aseptic Meningitis With Lamotrigine

FDA Green PharmacyFDA in conjunction with Glaxo-Kline, the makers of Lamictal announced a decision to update labels on the popular drug. In the announcement, health professionals and patients are advised that in rare cases it can cause aseptic meningitis. Lamictal is commonly used to treat seizures and bipolar disorder.

The decision to modify the labels is based on the FDA’s knowledge of cases from December 1994 to November 2009. Patients diagnosed with aseptic meningitis were also taking Lamictal. According to the released reports, when the lamictal regimen was stopped, the meningitis subsided.  

Patients are advised to contact their healthcare provider right away if they experience signs and symptoms of meningitis while taking Lamictal.  Symptoms include headache, fever, chills, nausea, stiff neck, vomiting, and Photophobia – sensitivity to light. Aseptic meningitis is an illness typified by severe swelling of the linings of the brain and spinal cord (i.e., meninges), usually with an accompanying mononuclear pleocytosis.

Patients should be evaluated if meningitis is suspected and treated for all instances of meningitis. Discontinuation of Lamictal is advised if no other origin of meningitis is identified. Aseptic meningitis is normally diagnosed when patients have the signs and symptoms of meningitis, but tests 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

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