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SILVER SPRING, Md. — The Food and Drug Administration has received reports of a rare and usually deadly cancer in patients using a class of biotech drugs to treat autoimmune and inflammatory diseases, the agency said Thursday.
The FDA warned that some patients taking tumor necrosis factor blockers had developed hepatosplenic T-cell lymphoma, or HSTCL, a fast-spreading cancer of the white blood cells. Most of the cases were in adolescents and young adults using TNF blockers to treat Crohn’s disease and ulcerative colitis, but cases of patients treating psoriasis and rheumatoid arthritis had emerged as well.
TNF blockers include Remicade (infliximab) and Simponi (golimumab), both made by Johnson & Johnson, Abbott’s Humira (adalimumab), UCB’s Cimzia (certolizumab pegol), and Enbrel (etanercept), made by Amgen and Pfizer. The agency said some cases also had emerged in patients taking azathioprine and mercaptopurine, immune-suppressant pharmaceutical drugs available as generics, alone and in combination with the TNF blockers. However, the agency also said that patients with the diseases those drugs treat are at higher risk of developing lymphoma than the general population.
Over the years, the FDA has received a number of reports of patients developing cancers or deadly viral infections like progressive multifocal leukoencephalopathy after taking immune-suppressant drugs for autoimmune and inflammatory disorders, though such cases are rare enough that the FDA generally has recommended that the drugs stay on the market.