FDA Date: 9/3/08
Enbrel (etanercept) FDA Drug Safety Communication
FDA Information for Healthcare Professionals: Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)
FDA is notifying healthcare professionals that histoplasmosis and other invasive fungal infections are not consistently recognized in patients taking tumor necrosis factor-alpha blockers (TNF blockers), eg, Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). FDA is requiring the manufacturers of TNF blockers to update the following:
- Boxed Warning and Warnings sections of the prescribing information, and the Medication Guide for patients, to highlight the risk of invasive fungal infections, such as histoplasmosis.
This information reflects the current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.