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Title: FDA: TNF Blockers Increase Risk of Invasive Fungal Infections, Delayed Treatment Can Result in Death
URL: http://www.pslgroup.com/dg/22ACA2.htm
Doctor's Guide
September 4, 2008

ROCKVILLE, Md -- September 4, 2008 -- The US Food and Drug Administration (FDA) is notifying healthcare professionals that histoplasmosis and other invasive fungal infections are not consistently recognised in patients taking tumor necrosis factor-alpha blockers (TNF blockers), certolizumab pegol (Cimzia), etanercept (Enbrel), adalimumab (Humira), and infliximab (Remicade). This has resulted in delays in appropriate treatment, sometimes resulting in death.

The FDA has received reports of patients developing pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections while taking TNF blockers.

In some patients, the diagnosis of histoplasmosis was initially unrecognised and antifungal treatment was delayed. Some of these patients died from histoplasmosis. There were also deaths in patients with coccidioidomycosis and blastomycosis.

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.

Consultation with an infectious diseases specialist should be sought when feasible. As with any serious infection, consider stopping the TNF blocker until the infection has been diagnosed and adequately treated.

Considerations for Healthcare Professionals
· Patients should be closely monitored during and after treatment with TNF blockers for the development of signs and symptoms of possible systemic fungal infection including fever, malaise, weight loss, sweats, cough, dypsnea, pulmonary infiltrates on X-ray, or serious systemic illness including shock.
o Patients who develop an infection should have their TNF blocker discontinued and undergo a complete diagnostic workup, which may include fungal cultures, histopathological or cytological evaluations, antigen detection and serum antibody titers.
· For patients who reside or travel in regions where mycoses are endemic, invasive fungal infections should be suspected if they develop the signs and symptoms of possible systemic fungal infection.
o The decision to administer empiric antifungal therapy in these patients should be made in consultation with an infectious diseases specialist with expertise in the diagnosis and treatment of invasive fungal infections when feasible.
· TNF blockers may be restarted after recovery from the infection. The decision to restart the TNF blocker should include a reevaluation of the benefits and risks of TNF blockers, especially in patients who live in regions of endemic mycoses.
o Both the decision to restart TNF blocker therapy and the duration of antifungal therapy should be made in consultation with an infectious disease specialist, when feasible.

The FDA will require the makers of the TNF blockers to further highlight the information about the risk of invasive fungal infections in the Boxed Warning and Warnings sections of the drugs' prescribing information and the Medication Guide for patients. FDA will also require that the makers of the TNF blockers to educate prescribers about this risk.

To report any unexpected adverse or serious events associated with the use of these drugs, please contact the FDA MedWatch program and complete a form on line at http://www.fda.gov/medwatch/report/hcp.htm or report by fax to 1-800-FDA-0178, by mail using the postage-paid address form provided on line, or by telephone to 1-800-FDA-1088.

SOURCE: US Food and Drug Administration

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