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Serious Fungal Infections Linked to TNF-alpha Blockers, Including Simponi
Source: The Food and Drug Administration The FDA and Centocor Ortho Biotech have informed health care professionals of the risk of serious invasive fungal infections associated with TNF-alpha blockers, including Simponi (golimumab). Histoplasmosis and other invasive fungal infections are not consistently recognized in patients taking other TNF-αlpha blockers including Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). This oversight has resulted in delays in prescribing appropriate antifungal treatment, sometimes resulting in death. It is important that all adverse events potentially associated with Simponi be reported to either Centocor at 1-800-457-6399 or to the FDA MedWatch program at 1-800-332-1088. Read the complete MedWatch 2009 Safety summary, including links to the Dear Healthcare Professional letter, Prescribing Information, Medication Guide and previous 2008 MedWatch alert at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm162802.htm. |
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