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FDA Warns of Rare Brain Inflammation With Glaxo's Lamictal

US Health Officials Warn Of Rare Brain Inflammation With Glaxo drug Lamictal

From Canadian Press DataFile (August 12, 2010)


WASHINGTON -- Federal health regulators are warning doctors and patients that an anti-seizure drug from GlaxoSmithKline can cause rare inflammation of the brain and spinal cord.

The Food and Drug Administration said Thursday it is working with the British drug maker Glaxo to add new warnings and labeling information to the company’s drug Lamictal.

The agency said it has received reports of 40 cases of aseptic meningitis between Lamictal’s approval in 1994 and last November. Thirty-five patients needed to be hospitalized, the agency said in a statement. The symptoms usually emerged within the first 45 days of treatment.

Aseptic meningitis is a dangerous inflammation of the brain and spinal cord that can cause headache, fever, chills and vomiting. 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 posted sales of $778 million last year, also is approved by the FDA to treat manic depression.

GlaxoSmithKline representatives could not immediately provide comment Thursday afternoon.

The company’s U.S-traded shares rose 88 cents, or 2.4 per cent, to $37.34 in afternoon trading.


Posted: August 2010