Life-Threatening Fungal Infection Linked to Arthritis Drugs

At Least 12 People Dead From Histoplasmosis

The Food and Drug Administration (FDA) has ordered the manufacturers of Humira, Cimzia, Enbrel, and Remicade to strengthen the warnings about the products because the medications are associated with a risk for opportunistic fungal infections, specifically histoplasmosis. Some patients have died from these infections.

The FDA became concerned after discovering information that doctors appeared to be overlooking cases of histoplasmosis. Of 240 incidents of the infection reported to the FDA, at least 21 cases were not initially recognized by health care professionals, and antifungal treatment was delayed. Twelve of those patients died. The majority of the reports involved people in the Ohio River and Mississippi River valleys where the fungus is commonly found.

The drugs, known as tumor necrosis factor alpha blockers (TNF-alpha blockers), work by suppressing the immune system. They are approved to treat a variety of conditions which may include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease.

SEPT-04-08: Makers of TNF-Blockers to Strengthen Warnings About Life-Threatening Fungal Infection [FDA: TNF-BLOCKER FUNGAL INFECTIONS]

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Published on Sep-4-08