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On September 4, 2008, the FDA announced that makers of tumor necrosis factor–α (TNF-α) blockers (adalimumab, certolizumab pegol, etanercept, and infliximab) will be required to further highlight existing information about invasive fungal infections, such as histoplasmosis, in a boxed warning and in the medication guide for patients.
Despite existing warnings about infection risk in the prescribing information for TNF-α blockers, the FDA has received numerous reports of pulmonary and disseminated fungal infections in patients taking these drugs. Healthcare workers have not consistently recognized the infections, leading to treatment delays. Some patients with histoplasmosis, blastomycosis, or coccidioidomycosis have died.
Patients taking TNF-α…