4 TNF-Blockers Get Stronger Warning Labels Due To Fatal Fungal Infection

By Dianna Cooper
14:00, September 7th 2008
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4 TNF-Blockers Get Stronger Warning Labels Due To Fatal Fungal Infection

The Food and Drug Administration ordered stronger and additional warnings about the risk of presumptive fatal fungal infections, particularly one called histoplasmosis, in people taking four arthritis drugs.

Known as tumor necrosis factor alpha blockers (TNF-alpha blockers), Cimzia, Enbrel, Humira and Remicade suppress the immune system to avoid damaging the human body.

The agency has received 240 reports of patients who took one of the four drugs and who contracted histoplasmosis, a disease caused by the fungus. Although it is a disease of the lungs, it can spread to other parts of the body. Among those patients, a number of 45 passed away, including no less than 12 who hadn’t been diagnosed immediately with the fungal infection and, therefore, antifungal treatment was put off, said Jeffrey Siegel at the FDA's Center for Drug Evaluation and Research.

Nearly all reports came from residents of Ohio River and Mississippi River valleys, two large areas where the fungus frequently grows.

Long-lasting fever, cough, and fatigue are some of histoplasmosis’ symptoms. Doctors strongly recommend people to get in touch with their health-care professionals right away after seeing “these signs and symptoms that are related to these types of infection,” Siegel affirmed during a press conference.

According to Reuters, the FDA notified that the manufacturers of the four abovementioned drugs would submit the new warnings within 30 days.



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