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A group of four drugs used to treat rheumatoid arthritis will get stronger warnings regarding the risk of potentially fatal fungal infections, the Food and Drug Administration announced on Thursday.
The agency said the drugs, which include Humira, Remicade, Enbrel and Cimzia, have been linked to 45 deaths due to a rare infection known as histoplasmosis. The FDA has received 240 reports of this type of infection in patients taking one of the four drugs.
Histoplasmosis mimics the flu and patients on these medications who develop symptoms such as persistent fever, fatigue, cough, or shortness of breath should contact a physician. If left untreated, the infection can spread to other organs from the respiratory system.
Dr. Jeffrey Siegel of the FDA called the drug treatment for rheumatoid arthritis patients “a double-edged sword,” since the drug’s work to suppress the immune system to provide relief from joint swelling and pain.
The four drugs are also being investigated for a possible link to cancer. According to the FDA, 30 cases of cancer—primarily lymphomas—have been reported among patients who began treatment prior to 18. That investigation is ongoing and results may not be available until next year.
(Source: The New York Times)
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