The Food and Drug Administration (FDA) has reported that doctors are not consistently recognizing histoplasmosis and other invasive fungal infections in patients taking Tumor Necrosis Factor-alpha (TNF-α) blockers: Cimzia, Enbrel, Humira, Remicade and Simponi. TNF-α blockers are commonly used to treat moderate to severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis or chronic arthritis in the spine.

The failure to recognize fungal infections has resulted in delays in appropriate antifungal treatment, sometimes even resulting in death.

Centocor Ortho Biotech and FDA recently reminded healthcare professionals of these risks associated with the TNF-α blocker Simponi. Centorcor Ortho Biotech of Horsham, PA manufactures Simponi.

Patients who develop an infection, including any persistent or reoccurring infections should have their Simponi or other TNF-α blocker discontinued. Empiric antifungal therapy should be considered until the source of the infection is identified. It may be appropriate to consult an infectious diseases specialist.

Patients and health care professionals are encouraged to report and to monitor signs of infection and be closely monitored during and after treatment with TNF-α blockers for invasive fungal infections. Symptoms include fever, malaise, weight loss, sweats, cough and dyspnea, pulmonary infiltrates on X-ray or serious systemic illness.

Patients who reside in or travel to regions where fungal infections are endemic like the Ohio and Mississippi River valleys and southwestern United States should be tested for invasive fungal infections if they develop a serious systemic illness.

All adverse events should be reported to Centocor Ortho Biotech or the FDA. It is important that all adverse events potentially associated with Simponi be reported so that the drug’s profile is updated appropriately as post-approval experience is gathered.

Centocor Ortho Biotech Inc. can be contact at 1-800-457-6399.

The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see: http://www.fda.gov/medwatch/safety/2009/SIMPONI_DHCP%20letter_May09.pdf
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Simponi

Labels: ankylosing spondylitits, arthritis, Cimzia, enbrel, FDA, fungal infections, humira, posriatic arthritis, remicade, rheumatoid arthritis, Simponi, spine, tnf-a