Catch-22: Stronger warnings on arthritis medications

Washington, D.C. ( – News Report) — The FDA has placed the arthritis treatment drugs Enbrel, Remicade, Humira and Cimziaon high warning. Arthritis is a disabling disease in which the immune system attacks the joints. These drugs have also been used to treat Crohn’s disease, juvenile arthritis, certain types of psoriasis, and other immune system disorders, providing relief from swollen and painful joints associated with those conditions. The four drugs are part of a group of drugs called TNF blockers , which suppress the action of tumor necrosis factor, a protein that can cause inflammation and lead to immune system-related diseases. However, TNF is also involved in the signaling of cell death or apoptosis, a response used by the immune system when tumor cells are detected.

The concern associated with the drugs is due to many doctors stating that the drugs can raise the risk of potentially fatal fungal infections. The infection, which is called histoplasmosis imitates the flu, and is known to have severe consequences if it isn’t caught early from spreading throughout the respiratory system and to other organs of the body.

What worries researchers and doctors are the 240 cases that have been reported to the FDA in which patients taking one of the four drugs developed the infection. Shockingly, a total of 45 died (nearly 20%). Therefore, the FDA’s order has indicated that these drugs be placed in the “black box,” the strongest warning information in a drug’s prescribing literature. This situation can truly be seen as a ‘catch-22’ in that the drugs help patients with arthritis, but at the same time, lower the body’s defenses to various kinds of infections.

In addition to this, the FDA’s Center for Drug Evaluation and Research (CDER) said it was investigating the possible link between TNF blockers and the development of lymphoma and other cancers in children and young adults. With 30 reports of cancers, mainly lymphoma in patients younger than 18, there appears to be a distinct relation. Reports have indicated that about half the cancers were of the lymphoma type, a cancer that affects the cells of the immune system, also included were leukemia, melanoma, and solid organ cancers. Long-term studies are necessary since shorter ones are not fully accurate for cancers that take time to develop.

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