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FDA Plans Stronger Warnings

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The Associated Press

Published: September 5, 2008

WASHINGTON - The Food and Drug Administration ordered stronger warnings Thursday on four medications widely used to treat rheumatoid arthritis and other serious illnesses, saying they can raise the risk of possibly fatal fungal infections.

The drugs - Enbrel, Remicade, Humira and Cimzia - work by suppressing the immune system to keep it from attacking the body.

For patients with rheumatoid arthritis, the treatment provides relief from swollen and painful joints, but it's "a double-edged sword," said the FDA's Jeffrey Siegel. That's because the drugs also lower the body's defenses to various kinds of infections.

Siegel, who heads the office that oversees arthritis drugs, said the FDA became concerned after discovering that doctors seemed to be overlooking a particular kind of fungal infection called histoplasmosis.

Of 240 cases reported to the FDA in which patients taking one of the four drugs developed this infection, a total of 45 died - about 20 percent.

The infection, which mimics the flu, is prevalent in much of the middle part of the country. It can have particularly grave consequences if it isn't caught early and spreads beyond the respiratory system to other organs of the body.

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