Stronger Warnings Issued for 4 Arthritis Drugs

Siegel said the FDA's order Thursday means that the risk of histoplasmosis will be flagged in a "black box," the strongest warning information in a drug's prescribing literature. The four medications already have black box warnings about the risk of infections, but the language varies from drug to drug.

Patients should call their doctors if they develop persistent fever, cough, shortness of breath or fatigue, which can be signs of the fungal infection.

The FDA also is urging doctors to consider aggressive use of antifungal drugs in patients who develop such symptoms, even if the infection has not been confirmed by a laboratory test. Siegel said such a decision should not be taken lightly, since antifungal drugs also can have dangerous side effects. Doctors should consider stopping treatment with the immune-suppressing drugs if patients develop infections.

The four drugs belong to a class known as TNF-alpha blockers and are considered a mainstay for treating rheumatoid arthritis and other immune system disorders.

The issue

The drugs work by suppressing the immune system to keep it from attacking the body. But they also lower the body's defenses to various kinds of infections.

Originally published by BY RICARDO ALONSO-ZALDIVAR.

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