Risk of fungal infection with TNF-blockers

The FDA and Centocor Ortho Biotech are reminding healthcare professionals of the risk of serious fungal infections associated with TNF-alpha blockers, including Simponi [golimumab]. Previously, the FDA reported that histoplasmosis and other invasive fungal infections are not consistently recognized in patients taking other TNF-alpha blockers including Cimzia (certolizumab pegol, from UCB), Enbrel (etanercept, from Amgen), Humira (adalimumab, from Abbott Laboratories), and Remicade (infliximab, from Centocor). This resulted in delays in appropriate antifungal treatment, sometimes even resulting in death.

Simponi is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis in combination with methotrexate, active psoriatic arthritis alone or in combination with methotrexate, or active ankylosing spondylitis

For more information call (800) 457-6399 or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm162802.htm.