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August 17, 2010
On August 12, 2010, the Food and Drug Administration (FDA) announced that the widely prescribed anti-seizure and bipolar medicine lamotrigine (LAMICTAL) (1.4 million prescriptions filled in 2009) can cause inflammation of the membranes covering the brain and spinal cord. The condition, called "aseptic meningitis," refers to inflammation in the absence of bacteria. The FDA will work with drug-maker GlaxoSmithKline to revise the "Warnings and Precautions" section of the...
August 17, 2010
On August 12, 2010, the Food and Drug Administration (FDA) announced that the widely prescribed anti-seizure and bipolar medicine lamotrigine (LAMICTAL) (1.4 million prescriptions filled in 2009) can cause inflammation of the membranes covering the brain and spinal cord. The condition, called "aseptic meningitis," refers to inflammation in the absence of bacteria. The FDA will work with drug-maker GlaxoSmithKline to revise the "Warnings and Precautions" section of the lamotrigine label accordingly.
Although meningitis is commonly thought to occur because of a bacterial infection, it can also be caused by viruses, chemicals, some vaccines, immune diseases, and, in this case, certain medications. If you are taking lamotrigine, look out for the following meningitis symptoms: headache, stiff neck, nausea, vomiting, rash, muscle aches, fever, and sensitivity to light. Depending on the cause, meningitis can be a life-threatening condition.
The FDA reached the decision to change lamotrigine's labeling after carefully reviewing adverse events submitted through the FDA MedWatch reporting system. Forty cases of aseptic meningitis were reported to the FDA from December of 1994 to November of 2009. During this period, 46 million prescriptions were dispensed. Although this adverse event is rare, patients should be aware of this potentially life-threatening condition.
In most instances, symptoms resolved when lamotrigine was discontinued. In 15 cases, symptoms recurred when the drug was restarted. In all known cases, there was only one death, which is not thought to have been caused by meningitis. However, 35 cases required hospitalization.
Although it is rare, aseptic meningitis can be caused by lamotrigine, and patients should be aware of this potential adverse reaction. Symptoms can occur from 1 to 42 days after taking the drug. If you are on this medication, and have the symptoms listed above, you should go to an emergency room immediately and mention this known association.
