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Enbrel, Humira, Remicade Undergoing Safety Review

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The Food & Drug Administration (FDA) is investigating Humira, Enbrel and Remicade for a possible link to cancer in children. The drugs are known as tumor necrosis factor (TNF) blockers, and are used to treat various forms of arthritis including juvenile idiopathic arthritis and Crohn’s disease. TNF blockers impede the action of a substance made by the body’s immune system called TNF. People with an autoimmune disease, such as rheumatoid arthritis, have too much TNF in their bodies.

The FDA is investigating about 30 reports of leukemia, lymphoma and other cancers in children and young adults submitted between 1998, after the approval of the first TNF blocker, through April of this year. Approximately half of the reports were lymphomas, cancer of the immune system cells, that were both Hodgkin’s and non-Hodgkin’s based.

The FDA has requested that makers of TNF blockers approved for use in children and young adults supply information about all reported cases of cancer among patients in these age groups taking the drugs. The FDA has also asked health-care professionals to weigh the possible risks against the benefits when prescribing TNF blockers.

Remicade is approved for use in children with Crohn’s disease. Enbrel and Humira are approved to treat children with juvenile rheumatoid arthritis, according to the FDA. All of the labels for the drugs currently address the possible risk of cancer when taking the drug.  The FDA is requiring the maker of a fourth TNF blocker, Cimzia, to conduct a study to assess long-term risks of the product, including lymphoma and other cancers.  This study will begin in 2009 and take about 10 years to complete.

In addition to the possible cancer risk, TNF blockers have been associated with an increased risk of some infections. In May, Enbrel had its label modified to include a black box warning – the FDA’s strictest safety alert – about its association with serious infections, including tuberculosis. The warning was prompted by global studies of over 20,000 patients taking Enbrel, where tuberculosis was observed in about 200 people.

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