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TNF-blocker Warnings

The Food and Drug Administration (FDA) is requiring makers of the tumor necrosis factor (TNF) blockers adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), and infliximab (Remicade) to strengthen label warnings about the risk of fungal infections. Some patients with invasive fungal infections have died, according to FDA officials.
   The four drugs, all TNF-alpha blockers, suppress the immune system and are used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease. The FDA is requiring the change in drug labels and medication guides because prescribers still aren't reliably recognizing histoplasmosis and other invasive fungal infections in patients receiving these drugs.
   Officials urge all health care providers to teach patients taking TNF blockers that these drugs increase the risk of serious fungal infection. Patients should be encouraged to seek medical care promptly for persistent fever, cough, shortness of breath, and fatigue. Patients should also tell health care providers where they live and areas they've visited recently; most reports of infection with Histoplasma capsulatum have occurred in the Ohio River and Mississippi River valleys.
   Patients who develop a fungal infection may need to stop TNF-blocker therapy until the infection resolves.










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