FDA Warns of Seizure Drug's Serious Side Effect

On August 12, the Food and Drug Administration (FDA) warned that the medication lamotrigine (Lamictal), which has been approved to treat seizures and bipolar disorder, can cause aseptic meningitis.

Aseptic meningitis is an inflammation of the protective membranes that cover the brain and spinal cord. It is known to have a number of causes—among them are viruses, toxic agents, some vaccines, autoimmune diseases, and certain medications, including lamotrigine.

Thomas Wise, M.D., medical director of behavioral services at Inova Health Systems in Falls Church, Va., a professor of psychiatry at John Hopkins University, and chair of the APA Council on Psychosomatic Medicine before it was sunsetted, offered the following guidance regarding the FDA's statement: “The co-occurrence of aseptic meningitis following Lamictal administration is a very rare, but serious situation that demands cessation of Lamictal. Both psychiatrists and neurologists use this agent and should warn their patients that the emergence of a serious headache, chills, nausea, and photophobia requires immediate evaluation and discontinuation of Lamictal, but also careful investigation of other potential causes.”

The FDA became aware of the association between lamotrigine and aseptic meningitis through routine adverse-event monitoring and communications with the drug's manufacturer, GlaxoSmithKline. From the time of the drug's approval in December 1994 through November 2009, there were 40 cases of aseptic meningitis reported in patients taking the medication.

The symptoms were reported to occur within one to 42 days after starting lamotrigine. Thirty-five of the 40 patients required hospitalization. In most cases, symptoms ended after the medication was discontinued. In 15 cases, symptoms—often more severe—returned when patients restarted the drug.

The FDA is working with GlaxoSmithKline to update the prescribing information about Lamictal as well as the patient medication guide to include the aseptic meningitis risk.

More information about Lamictal's aseptic meningitis risk is posted at <www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm221847.htm> and at <www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm196029.htm>.