FDA Warns of Deadly Fungal Infections in Users of New Arthritis Drug

A newly approved drug for the treatment of moderate to severe rheumatoid arthritis can cause deadly fungal infections, the Food and Drug Administration is warning.

Simponi, a TNF-alpha blocker made by Centocor Ortho Biotech Inc., was approved by the FDA in April. It also is available in generic form as golimumab and approved to treat active psoriatic arthritis and active ankylosing spondylitis, two severe chronic disorders which cause joint pain, stiffness, and limited movement.

The FDA said today that it has received numerous reports of histoplasmosis and other types of invasive fungal infections in people taking Simponi and other brands of TNF-alpha blockers such as Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), and Cimzia (certolizumab pegol).

TNF-alpha blockers work by targeting a specific protein that causes inflammation and damage to bones, tissue, and cartilage when there is too much of it in the body.

When the FDA approved Simponi last month, the drug’s package labeling was required to carry a prominent “Black Box” warning about the risk of developing tuberculosis and invasive fungal infections. Other listed side effects of Simponi included upper respiratory tract infections, sore throat, and nasal congestion, the FDA said.

The fact that the invasive fungal infections are not easily detected in some patients taking the TNF-alpha blockers for arthritis and other conditions has caused delays in treating the infections, the FDA said. In an undisclosed number of cases, patients have died from the infections.

The FDA is cautioning healthcare professionals who treat patients taking Simponi and other brands of TNF-alpha blockers for rheumatoid arthritis to keep a watchful eye on patients to assist the agency in developing an adverse event profile for Simponi.

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