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FDA warns of arthritis drugs infection risk
Infection Control Monitor, September 12, 2008
The Food and Drug Administration (FDA) on September 4 ordered stronger warnings on four medications widely used to treat rheumatoid arthritis, saying the drugs can raise the risk of developing opportunistic fungal infections.
The four medications are Enbrel, Remicade, Humira, and Cimzia. The FDA said the manufacturers of the TNF-alpha blocker drugs must strengthen existing warnings. Some patients with invasive fungal infections have died, the agency said in a press release.
The drugs work by suppressing the immune system to keep it from the attacking the body. While they provide relief from swollen and painful joints for patients with rheumatoid arthritis, they also lower the body’s defenses to infections.
Based on reports it has reviewed, the FDA said healthcare professionals are not consistently recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in patient treatment. Patients taking TNF blockers, who develop a persistent fever, cough, shortness of breath, or fatigue, should seek medical attention, the FDA said. For more information, click here.
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