After receiving numerous reports of serious fungal infections among patients taking tumor necrosis factor (TNF) blockers—infections that in some cases resulted in prolonged hospitalizations and death—the US Food and Drug Administration (FDA) has ordered manufacturers of the drugs to add a stronger warning to their label.
Labeling for these immunosuppressive drugs already warns that they may cause severe infections. But the agency has received some reports suggesting that physicians may have been slow to diagnose fungal infections among patients taking these drugs, leading to treatment delays and poorer outcomes. TNF- blockers are used to treat a range of disorders, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn disease.
The FDA has reviewed 240 reports of histoplasmosis in patients being treated with etanercept, adalimumab, and infliximab. Treatment was delayed because physicians initially failed to recognize the condition in at least 21 . . .
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