FDA Notice: Lamictal May Cause Aseptic Meningitis in Rare Cases

August 19, 2010 10:51 am

FDA is alerting health care providers and patients that Lamictal^® (lamotrigine), a medication commonly used for seizures in children two years and older, and bipolar disorder in adults, can cause aseptic meningitis. It is important to rapidly diagnose the underlying cause of meningitis – which is an inflammation of the meninges that cover the brain and spinal cord – so that treatment can be promptly initiated. Symptoms of meningitis may include headache, fever, stiff neck, nausea, vomiting, rash, and sensitivity to light. Aseptic meningitis is generally diagnosed when tests detect that no bacteria is present in a patient with signs and symptoms of meningitis. Causes of aseptic meningitis include viruses and other non-bacterial infections, toxic agents, some vaccines, malignancy, and certain medications, including Lamictal.

FDA advises health care providers that 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.

FDA is revising the “warnings and precautions” section of the Lamictal drug label and the patient Medication Guide to include information about the risk. FDA notes that 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 over 46 million prescriptions for Lamictal were dispensed. Additional information is available in an FDA Drug Safety Communication.