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August 7th, 2009
FDA Demands TNF Blockers to Include Cancer Warnings

The US FDA requires TNF blockers to include firm detailed warnings in the prescribing information.  The warnings, which also involves an up to date box warning, spotlights the increase chance of cancer in children and adolescents who first obtain the drug to treat juvenile rheumatoid arthritis, inflammatory bowel disease, Crohn’s disease and other inflammatory diseases.

As well as, the FDA is determined to act alongside the manufacturers and consider new ways of further clarifying the risk of cancer in the children and adolescents who use the drugs.

TNF blockers are used to focus on and nullify factor-alpha, a protein that when becomes overproduced can lead to chronic inflammatory diseases, causes inflammation and bone, cartilage and tissue damage.  Drugs in this category include: Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia (cetrolizumab pegol) and Simponi (golimumab).

The FDA’s action is a result of the finalization of their investigation.  Their analysis of U.S reports found that cancer in children and adolescents administered with TNF-blockers proved an increased cancer risk occurring on average after 30 months of treatment.  Roughly, half the cancers were lymphomas and some were revealed to be lethal.


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