The Food and Drug Administration ordered stronger warnings about the risk of potentially deadly fungal infections on four medications widely used to treat rheumatoid arthritis and other serious illnesses. The FDA has received 240 reports of patients taking such drugs as Cimzia, Enbrel, Humira, and Remicade, known as TNF-alpha blockers, who said the drug lowered the body’s defense to infections. Overall, 45 patients died. They developed histoplasmosis, a fungal infection which spreads throughout the body.
The drugs work by suppressing the immune system to keep it from attacking the body and they are approved to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis and Crohn’s disease. But the treatment can leave patients vulnerable to other complications, or diseases.
“FDA has asked the manufacturers of these four drug products to highlight existing warnings of fungal infections,” Dr. Jeffrey Siegel, clinical team leader at the FDA…He added that the box warning must be upgraded to “strongly warn doctors to consider the occurrence of histoplasmosis and other fungal infections.”
The agency is also investigating a possible link between the four medications and cancer in young patients. The FDA had received 30 reports of cancers, mainly lymphomas, in patients who began taking the medications when they were 18 or younger. The agency said it has a six-month timeline for the review. “We intend to meet that timeline,” Siegel said.
Scary stuff. Once again, you have to question the thoroughness of FDA pre-release testing.