TNF-blocker drug manufacturers must strengthen warnings

September 11, 2008

Mandate comes in regard to the risk of invasive fungal infections.

The makers of Humira, Cimzia, Enbrel, and Remicade have been ordered by the Food and Drug Administration to strengthen the warnings on their labels due to the risk of invasive fungal infections.

The drugs are used to treat a variety of conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease. Some patients using the TNF-blockers have developed opportunistic fungal infections and died. "Requiring the risks to be highlighted will help heath care professionals be more vigilant in watching for these adverse events, and is necessary to ensure that the benefits of these drugs outweigh their risks," Bob Rappaport, a FDA director, said.

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