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Arthritis Drugs Get New Warnings About Kids and Cancer

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Remicade, Enbrel, Humira, Cimzia and Simponi, drugs known as TNF blockers, will bear stronger warnings about their association with various forms of cancers when they are used to treat children, the Food & Drug Administration (FDA) said yesterday.

In children, TNF blockers are used to treat rheumatoid arthritis, inflammatory bowel disorder and Crohn’s disease. They are also approved to treat a variety of chronic, inflammatory and autoimmune system diseases including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. TNF blockers work by neutralizing a protein that, when overproduced, causes inflammation and damage to bones, cartilage and other tissue.

The drugs already carry a black-box warning that they may cause cancer. But the FDA said yesterday the Boxed Warnings must highlight the drugs’ possible risk of lymphoma and other cancers in children and teens.

According to a notice posted on the FDA’s Website on yesterday, the agency has identified 48 cases of malignancies in children and adolescents treated with TNF blockers. Approximately half were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. Other malignancies reported include leukemia, melanoma, and solid organ cancers. Malignancies such as leiomyosarcoma, hepatic malignancies, and renal cell carcinoma, which are rare in children, were also reported.

Of the 48 cases of cancer, there were 11 deaths, the FDA said. The causes of death included hepatosplenic T-cell lymphoma (9 cases) and T-cell lymphoma (1 case). In the remaining case, the patient died from sepsis after achieving remission of the lymphoma.

The FDA is requiring  manufacturers of TNF blockers to update the Boxed Warning in the prescribing information to alert healthcare professionals of an increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers. Along with updating the drugs’ labels, the FDA is requiring companies to add information about cancer risks to patient medication guides. The FDA said it is also working with the manufacturers to further define the scope of the cancer risk.

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