The FDA announced today that four drugs used to treat rheumatoid arthritis and other serious illnesses will now have stronger black box warnings due to the increased risk of fatal fungal infections. A black box warning is the strongest warning the FDA gives before pulling the product from commercial use.
The four drugs – Cimzia, Enbrel, Humira, and Remicade – suppress the immune system to keep it from attacking the body. This allows relief from swollen and painful joints in patients with rheumatoid arthritis, but also lowers the body’s defenses against other infections.
The FDA became concerned when they discovered that doctors were overlooking histoplasmosis, a kind of fungal infection. Of the 240 cases reported to the FDA, 45 patients died, a rate of nearly 20 percent. Histoplasmosis is more common in the middle of the U.S. and mimics the flu. If it is not caught early on and spreads from the respiratory system to other organs, it becomes deadly. Another concern of the FDAs is that doctors may not recognize histoplasmosis when their patients show symptoms. When looking at their database, FDA officials found that of the 240 patients who had been taking the medications and developed the infection, 21 received a late diagnosis. Twelve of those 21 later died.
While the four medications already have a black box warning about the risk of infections, the language varies on each drug. Patients will now be told to alert their doctors if they develop a cough, persistent fever, fatigue or shortness of breath since these are all symptoms of a fungal infection. The FDA also has begun urging doctors to “consider” the use of antifungal drugs in patients who develop symptoms of histoplasmosis. Because these antifungal drugs also have serious side-effects, the FDA says the decision should not be made lightly – which shows the seriousness of histoplasmosis.
Known as TNF-alpha blockers, the drugs are also used to treat Crohn’s disease, juvenile arthritis, some kinds of psoriasis, and more. They are all delivered by injection and, with the exception of the newest and less widely used Cimzia, have brought in sales of over one billion dollars annually.
