Resources for Food and Drug Administration (FDA)

Another FDA Safety Warning

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Another day, another warning from the Food and Drug Administration.

Such is the new paradigm for drug developers. The FDA is going to make darn sure consumers know everything about every possible side effect that a drug could cause.

The latest victim was the TNF inhibitors -- Amgen's and Wyeth's Enbrel, Abbott Labs' Humira, UCB's Cimzia, and Johnson & Johnson's Remicade, which is sold outside the U.S. by Schering-Plough. These drugs inhibit the immune system to treat rheumatoid arthritis, Crohn's disease, and other autoimmune conditions. The FDA warning results from numerous reports of fungal infections in patients taking the TNF inhibitors, including 12 deaths.

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