Stronger Warnings For TNF Blocker Medications

By Jenny Huntington
22:06, September 5th 2008
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Stronger Warnings For TNF Blocker Medications

Due to the fact that dozens of patients contracted severe fungal infections and died after taking prescription drugs for rheumatoid arthritis, Crohn's disease and other medical conditions, the Federal Drug Administration urged that warnings on the medications’ packaging should be stronger. Consequently, the warnings will be letting doctors know of the possibility of fungal infections in those patients who are seriously ill or not responding to current treatment. Clinical team leader in the FDA's Division of Anesthesia, Analgesia and Rheumatology Products Jeffrey Siegel, stated that the infections need to be identified early in order to begin the treatment as soon as possible.

The drugs that treat the aforementioned diseases work by suppressing the immune system to combat inflammation. A number of  240 patients that were taking Enbrel, Humira or Remicade reported infections caused by the fungus Histoplasma capsulatum, 45 of which died because doctors had not caught the infection in due time. Most of the infected patients lived near the Ohio River and the Mississippi River valleys.

The FDA announced that companies are to submit the new warnings within thirty days or otherwise present their reasons for protest.

The regulations aim at drawing more attention to histoplasmosis, which is a disease that targets the respiratory system. Its symptoms include fever, cough, shortness of breath and fatigue, thus rendering it quite difficult to be told apart from a corny flu.

Currently, the FDA is looking into the possibility that these drugs may be responsible for cancer in young patients. The investigation’s results are to be offered to the public approximately six months from now.



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