The drugs include Enbrel, Remicade, Humira and Cimzia, act by putting down the immunity system to keep it from attacking the body. The treatment provides relief from painful and swollen joints in patients of rheumatoid arthritis, but it’s “a double-edged sword,” said the FDA’s Dr. Jeffrey Siegel, because these drugs also weaken the body’s defense to multiple infections.

Siegel said the FDA became alarmed after discovering that some doctors have neglected a special kind of fungal infection called histoplasmosis. Around 240 cases of this infection reported to the FDA out of which, 20 percent of patient died.

Investigation starts with a woman case that died because of fungal infection. She was taking one of these drugs. “This case led us to be concerned that there may be other situations in which physicians may not recognize histoplasmosis,” said Siegel.

FDA officials review the agency’s database and found 240 more cases; taking the medications had also developed the fungal infection. Of those, at least 21 appeared to have a late diagnosis and more than half ultimately died.

Siegel said “the FDA’s order Thursday means that the risk of histoplasmosis will be flagged in a black box, the strongest warning information in a drug’s prescribing literature.”

If arthritis patients develop constant fever, cough, fatigue or shortness of breath, which can be signs of the fungal infection. They are recommended to call their doctor immediately.

FDA is also advising doctors to consider use of antifungal drugs in such patients who show these symptoms, even if the infection has not yet been confirmed. Siegel said “such a decision should not be taken lightly, since antifungal drugs can also have dangerous side effects. Doctors should also consider stopping treatment with the immune-suppressing drugs.”

The four drugs belong to TNF-alpha blockers, and are also used for the treatment of Crohn’s disease, juvenile arthritis, certain types of psoriasis, and other conditions. Three of the drugs, Enbrel, Humira and Remicade, are blockbusters and each having a sale of over one billion US dollar annually. Cimzia is newer and less widely used. All are administered by injection.

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