Fungal infection warning strengthened for TNF-blockers
The FDA is requiring the manufacturers of tumor necrosis factor (TNF)-blockers to strengthen their existing warnings of opportunistic fungal infections in their prescribing information. While these warnings do appear in the TNF-blockers' labeling, there have been reports of health care professionals not recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment, sometimes resulting in death. The manufacturers of the following products: Humira (adalimumab, from Abbott), Cimzia (certolizumab, from UCB), Enbrel (etanercept, from Amgen and Wyeth) and Remicade (infliximab, from Centocor) are required to submit these labeling changes.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm163195.htm.