Special Alerts:

[Posted 09/04/2008] FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dypsnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses. For patients at risk of histoplasmosis and other invasive fungal infections, clinicians should consider empiric antifungal treatment until the pathogen(s) are identified. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF2, http://www.fda.gov/cder/drug/InfoSheets/HCP/TNF_blockersHCP.htm and http://www.fda.gov/bbs/topics/NEWS/2008/NEW01879.html.

[Posted 06/03/2008] FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF and http://www.fda.gov/cder/drug/early_comm/TNF_blockers.htm.

[Posted 05/01/2008] Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for etanercept (Enbrel). The revisions include a BOXED WARNING about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with etanercept. Infections have included bacterial sepsis and tuberculosis. The ADVERSE REACTIONS section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with etanercept. Healthcare professionals should screen patients for latent tuberculosis infection before beginning etanercept. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with the drug. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, etanercept should be discontinued. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Enbrel, http://www.fda.gov/medwatch/safety/2008/AmgenDearHCPLetter.pdf and http://www.fda.gov/medwatch/safety/2008/enbrel_pi.pdf.