Serious Fungal Infections with Simponi (August 2009)

FDA is reminding healthcare professionals about the risk of serious fungal infections with TNF blockers, including Simponi (golimumab), which was recently approved. TNF blockers are immunosuppressants used to treat chronic inflammatory diseases, including rheumatoid arthritis. FDA had previously warned about the risk of serious fungal infections associated with TNF blockers, including Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab) and Remicade (infliximab). FDA is concerned that invasive fungal infections, including histoplasmosis, have not been consistently recognized in patients taking these drugs, resulting in delayed treatment and, in some cases, death.

In a recent letter to clinicians, Centocor Ortho Biotech, the manufacturer of Simponi, recommended that patients be closely monitored for signs of invasive fungal infections during and after treatment with TNF blockers. The company's letter said that TNF blockers, including Simponi, should be discontinued if such infections occur, and suggested that clinicians consider empiric antifungal therapy until the specific pathogens can be identified.

Category:

Science & Technology

Tags:

• Fungal Infection
• Simponi
• TNF Blocker
• Immunosuppressants
• Rheumatiod Arthritis
• FDA
• Cimzia
• Enbrel
• Remicade
• Histoplasmosis
• Death
• Patient Safety