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FDA Warns of Aseptic Meningitis Risk With Use of Lamotrigine ROCKVILLE, Md -- August 12, 2010 -- The US Food and Drug Administration (FDA) today warned that the drug lamotrigine (Lamictal), approved to treat seizures and bipolar disorder, can cause aseptic meningitis. The agency is working with the drug's manufacturer, GlaxoSmithKline, to update the prescribing information and patient medication guide to include this risk. Aseptic meningitis has a number of causes including, but not limited to, viruses, toxic agents, some vaccines, autoimmune diseases, and certain medications, including lamotrigine. Symptoms can include headache, fever, chills, nausea, vomiting, stiff neck, and sensitivity to light. Hospitalisation may be required. In suspected cases of meningitis, the underlying cause should be rapidly diagnosed so that treatment can be promptly initiated. Discontinuation of lamotrigine should be considered if no other clear cause of meningitis is identified. "Aseptic meningitis is a rare but serious side effect of [lamotrigine] use," said Russell Katz, MD, Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, Rockville, Maryland. "Patients that experience symptoms should consult their healthcare professional immediately." The FDA became aware of the association between lamotrigine and aseptic meningitis through routine adverse event monitoring and communications with the drug's manufacturer. Since the drug's approval in December 1994 through November 2009, there were 40 cases of aseptic meningitis identified in patients taking lamotrigine. The symptoms were reported to occur within 1 to 42 days after starting lamotrigine. Thirty-five of the 40 patients required hospitalisation. In most cases, symptoms ended after lamotrigine was discontinued. In 15 cases, symptoms, often more severe, returned when patients restarted the drug. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version