Tuesday, 9 September 2008

FDA Alert: TNF-blockers can increase the risk of fungal infection

The FDA is concerned that it is not widely enough known that the use of TNF-blockers (used to treat a variety of conditions such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease) also suppresses the immune systems of patients taking the drug.

Patients with a suppressed immune system are more vulnerable to potentially serious and difficult to treat infections such as Aspergillosis.

The announcement went as follows:
FDA ALERT [9/4/2008]: FDA is notifying healthcare professionals that histoplasmosis and other invasive fungal infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). This has resulted in delays in appropriate treatment, sometimes resulting in death.

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 unrecognized 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.

FDA will require the makers of the tumor necrosis factor-α blockers (TNF blockers) to further highlight the information about the risk of invasive fungal infections, such as histoplasmosis, 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 educate prescribers about this risk.

More detail of this report here.

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