TNF Blockers get an added warning

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The FDA is requiring drug makers of tumor necrosis factor (TNF) blockers to include an additional warning to their product label, cautioning of an increased risk for Hepatosplenic T-Cell Lymphoma (HSTCL), a type of blood cancer primarily reported in adolescents and young adults on TNF blockers.

TNF blockers are a class of anti-inflammatory, immunomodulating drugs that may be used to treat a variety of inflammatory and autoimmune disorders, including Crohn’s disease and ulcerative colitis as well as other ailments, like psoriasis and rheumatoid arthritis. Children and adolescents taking these medications, such as Merck & Co Inc.’s and Johnson & Johnson’s Remicade and Simponi, Amgen Inc.’s Enbrel, Abbott Laboratories Inc.’s Humira or UCB SA’s Cimzia, were previously warned by the FDA of their increased risk of lymphomas and other cancers.

Since TNF blockers operate by suppressing the immune system, it is expected that certain infections and neoplasms (abnormal growths including some cancers) may arise, says ACSH's Dr. Gilbert Ross. “A warning may well be appropriate, but the actual risk needs to be determined, and ultimately, the decision to prescribe these medications should be left up to the patient and their doctor.”

ACSH's Dr. Elizabeth Whelan also points out how the increased risk for blood cancer is actually credible in this scenario, unlike the unproven health maladies associated with environmental chemicals as cited by radical activist groups.