Arthritis Foundation Comment On Food And Drug Administration Ongoing Safety Review Of Tumor Necrosis Factor (TNF) Blockers

Main Category: Cancer / Oncology
Also Included In: Arthritis / Rheumatology
Article Date: 10 Jun 2008 - 4:00 PDT

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The Food and Drug Administration (FDA) issued an early communication on June 4, 2008 regarding an ongoing safety review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) and the possible association between the use of these medicines and the development of lymphoma and other cancers in children and young adults.

The FDA is investigating approximately 30 reports of cancer in children and young adults who were treated with TNF blockers for Juvenile Idiopathic Arthritis (JIA), Crohn's disease or other diseases. JIA is the new name for what was called Juvenile Rheumatoid Arthritis (JRA). These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 after approval of the first TNF blocker, and extending through April 29, 2008.

The Arthritis Foundation supports the Food and Drug Administration's further study into the risk of cancer conferred by treating JIA with TNF blocker therapy. At this time, the increased risk of cancer does not seem to be large especially when compared to the risk of disability from untreated juvenile arthritis.

The Arthritis Foundation recommends that adult patients and parents of children being treated with TNF blockers work closely with their physicians to understand the risks and benefits clearly. The concern over increased risk of adverse side effects of these powerful drugs emphasizes the need for a national registry for patients with JIA and a network of collaborating treatment centers so that full information can be acquired about the risks and benefits of the new treatments that are becoming available.

The Arthritis Foundation is working toward this goal through its support for the Childhood Arthritis & Rheumatology Research Alliance (CARRA). CARRA is a North American organization of pediatric rheumatologists who have joined together to answer critical clinical research questions and determine the best possible treatment options for childhood arthritis and other childhood rheumatic diseases.

The Arthritis Foundation

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