A new TNF-alpha blocker called  Simponi may  cause severe and potentially fatal fungal infections, according to a  new “Dear Healthcare Professional” letter recently issued by Centocor Ortho Biotech, Inc.  Simponi was only approved in April as a treatment for adult patients with: moderate to severe rheumatoid arthritis in combination with methotrexate, psoriatic arthritis (either alone or in combination with methotrexate), and ankylosing spondylitis.

In the letter, Centocor Ortho  warns that invasive fungal infections are not consistently recognized in patients taking  TNF-alpha blockers.  This has resulted in delays in appropriate antifungal treatment, sometimes even resulting in death.  For patients who reside or travel in regions where mycoses are endemic (eg, Ohio and Mississippi River valleys and southwestern United States), invasive fungal infection should be suspected if they develop a serious systemic illness,  the letter  warns.

Centocor Ortho’s letter also advises doctors to  carefully review  Simponi’s prescribing information, which includes  important information about the risk of serious infections including TB and invasive fungal infections, such as histoplasmosis, in a Boxed Warning.  When making a decision to use Simponi, doctors must balance the potential benefits with the potential risks of therapy based upon a patient’s individual need, the letter says.

Doctors should encourage patients to report signs of infection and be closely monitored during and after treatment with Simponi and other TNF-alpha blockers for the development of invasive fungal infection. Signs and symptoms of  such disorders include fever, malaise, weight loss, sweats, cough and dyspnea,  pulmonary infiltrates on X-ray or serious systemic illness.   TNF-alpha blockers should be discontinued in patients who develop such symptoms, and they should undergo a complete diagnostic workup.  Once an infection has cleared, use of Simponi and other TNF-alpha blockers may be restarted based on a reevaluation of risks and benefits, th letter says.

TNF-alpha blockers work by suppressing the immune system.  Other drugs in this class include Humira, Cimzia, Enbrel, and Remicade. It has long been known that people taking TNF-alpha blockers run a risk of developing opportunistic infections, including  histoplasmosis, an infection caused by the fungus Histoplasma capsulatum.    Last fall, the Food & Drug Administration ordered the makers of TNF-alpha blockers to strengthen the existing warnings about opportunistic fungal infections linked to the drugs.