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Anti-Inflammation Drugs May Raise Cancer Risk 6-5-08
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.
Comment:
Tnf blocking medications are nothing to mess around with. Most of them have the side effect of death! JIA, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis I have found to be almost 80% of the time to be never diagnosed Celiac Disease and when all grains are cut out of the diet those "diseases" disappear. Please get properly tested for Celiac Disease. This entails an actual sampling of the stomach or intestines. Don't be fooled by anything else and don't except anything else; the rest of your life my depend on it!