Labeling updates and warnings through October 2008 for adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), and rituximab (Rituxan)

FDA has notified the manufacturers of adalimumab (Humira, Abbott), certolizumab pegol (Cimzia, UCB), etanercept (Enbrel, Amgen/Wyeth), and infliximab (Remicade, Centocor) that the labeling for these drugs must be changed to strengthen warnings regarding the risk of development of opportunistic fungal infections. Although the prescribing information for these drugs already contains information about this risk, reports received by FDA have suggested that healthcare professionals are not consistently recognizing cases of histoplasmosis and other invasive fungal infections in patients treated with these agents, which could lead to delays in treatment. These treatment delays could result in death.

Genentech and Biogen Idec have notified healthcare professionals that a case of progressive multifocal leukoencephalopathy (PML) leading to death has been reported in a patient with rheumatoid arthritis who was treated with rituximab (Rituxan) in a long-term safety extension clinical trial. The prescribing information for rituximab has been updated to reflect this new information.