Humira, Enbrel, Remicade Linked to 48 Pediatric Cancers and 11 Deaths

From 2001 through 2008, the Food and Drug Administration received 48 reports of cancers in children and adolescents treated with TNF blockers such as Humira, Enbrel, and Remicade, the agency said.

Among those cases, there were 10 cases of hepatosplenic T-cell lymphoma, seven cases of non-Hodgkin’s lymphoma, six cases of leukemia, and six cases of Hodgkin’s lymphoma. The cancers were reported in children treated with various doses of the drugs and no single dose was associated with a higher cancer rate, the FDA said.

There were 32 cancer cases reported in the United States and 16 reports came from outside the U.S., according to the FDA.

TNF blockers are used to treat a variety of diseases and disorders, but they are most often used in children to treat inflammatory bowel disease, rheumatoid arthritis, and Crohn’s disease. Besides Humira, Enbrel, and Remicade, other popular brand names of TNF blockers are Cimzia and Simponi.

FDA Investigates Cancer Link

Last year, the FDA launched an investigation into a link between the use of TNF blockers and cancer in children. The FDA recently announced that there had been 11 deaths among the 48 cancer cases. Those deaths were caused by T-cell lymphoma and sepsis after reaching remission of the lymphoma.

Last month, the FDA ordered the makers of TNF blocker drugs to include stronger warnings about the cancer risks on the products’ packaging. The FDA also required the drugs to update the prescribing information to include the risk of the chronic skin disease psoriasis associated with the use of the drugs.

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