Federal health regulators are warning doctors and patients that Lamictal, an anti-seizure drug from GlaxoSmithKline PLC, can cause rare inflammation of the brain and spinal cord. The Food and Drug Administration said on August 12th that it is working with the British drugmaker Glaxo to add new warnings and labeling information to the drug.
The FDA said it has received reports of 40 cases of aseptic meningitis between 1994, when Lamictal was approved, and last November. Thirty-five patients needed to be hospitalized, the agency said in a statement. Aseptic meningitis is a dangerous inflammation of the brain and spinal cord that can cause headache, fever, chills and vomiting. The symptoms usually emerged within the first six weeks of treatment. The problem can be caused by viruses, toxins and certain medications. Treatment for the illness, which usually resolves itself in two weeks, generally involves pain medications.
Lamictal is part of the anti-seizure family of medications. The drug, which had sales of $778 million last year, is also approved by the FDA to treat manic depression. GlaxoSmithKline says it will add language about the risk to a medication guide distributed to patients. Even though the company says aseptic meningitis is a “very rarely reported event,” it is a very serious illness. We will continue to monitor this situation.
Source: Associated Press
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