Credit: FDA

THURSDAY June 5, 2008 (foodconsumer.org) -- The Food and Drug Administration on June 4 issued a statement saying it is investigating the potential association between use of tumor necrosis factors blockers (TNF) and the development of lymphoma and other cancers in children and young adults.

TNF blockers suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation leading to immune system-related diseases including JIA, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis.

The drugs of concern include Enbrel, sold by Amgen and Wyeth; Remicade, sold by Johnson & Johnson and, in Europe, by Schering-Plough; Humira, sold by Abbott Laboratories; and Cimzia, sold by UBC, a Belgian company, according to the New York Times.  

These TNF blockers are available in the United States and indicated for treatment of immune system-related diseases. Remicade, Humira and Enbrel combined earned $17 billion in sales last year, the times reported.

The FDA has received about 30 reports of cancer over a ten-year period from 1998 through April 31, 2008.  Nearly half the cases are lymphoma including Hodgkin’s disease and non-Hodgkin’s lymphoma, which are cancers of the cells in the immune system.  Lymphoma is not a recognized complication of JIA or of Crohn’s disease, meaning that the drugs may potentially raise the cancer risk.

The cases were voluntarily reported to the FDA's Adverse Event Reporting System since 1998 after the first TNF blocker was approved.  The actual rate of implications with the use of these medicines could be higher.

These drugs are often taken along with other immuno-suppressive medicines such as such as methotrexate, azathioprine or 6-mercaptopurine.  Because of this, it makes it harder to know which immuno-suppressive drugs play a major role in the cancer risk.

The FDA said it is has been aware of the potential cancer causing effect of these medicines because they suppress the immune response.  The prescribing information for all four TNF blockers has already included warnings about the risk.

The agency acknowledged in its statement that "Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies."

In addition, the FDA knows the risk of hepatosplenic T cell lymphoma in children and young adults with Crohn's disease treated with Remicade and immunosuppressive drugs such as azathioprine or 6-mercaptopurine. This risk was acknowledged in the Remicade prescribing information in 2006.

For the safety review of these TNF blockers, the FDA required the manufacturers to submit information about all cases of cancer reported in children taking these medicines.  It also asked the maker of Cimzia to conduct a study to assess long-term risks of the product. The study will be launched in 2009 and would take ten years to complete.

At the present time, the FDA said it believes the potential benefits of the use of TNF blockers outweigh the potential risk in certain children and young adults.  But it suggested healthcare providers, parents and caregivers should consider the potential risk of lymphoma and other caner in children and young adults when deciding how to best treat the patients.

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