Humira, Other TNF Blockers Linked to Cancer in Children

January 12, 2010
By Gabriel Mejia, Esq. on January 12, 2010 12:01 PM | | Comments (0)

The U.S. Food and Drug Administration (FDA) recently announced that it would require Humira and other tumor necrosis factor (TNF) blocker prescription medications to include its strictest warning on both the packaging and prescribing information for the potentially dangerous drugs. The 'boxed warning' or 'black box warning' is now required after analysis of adverse medical incident reports submitted to the FDA showed an increased risk of lymphoma and other cancers with the use of TNF blockers such as Humira, Enbrel, Remicade and Cimzia in children and young adults. The FDA is requiring that manufacturers warn doctors and patients of the increased risk of leukemia, as well as new-onset psoriasis, on the TNF blocker packaging.



TNF blockers such as Humira, Enbrel, Remicade and Cimzia are used to treat children and young adults with Juvenile Idiopathic Arthritis (also known as Juvenile Rheumatoid Arthritis), Crohn's disease and other diseases. The drugs work by suppressing the immune system to block the tumor necrosis factor which causes inflammation and immune system related diseases.

The black box warning for TNF blockers comes after approximately 30 reports of cancer in children and young adults under the age of 18 taking TNF blockers were reported to the FDA between 1998 and April 2008. The concern included the development of lymphoma (cancer of the cells in the immune system) and other cancers such as leukemia, melanoma and solid organ cancers in children taking TNF blockers such as Humira, Enbrel, Remicade and Cimzia. In August 2009, the FDA announced that it had tracked 48 malignancies from 2001 through 2008 associated with the use of TNF blockers in children after an average of 30 months of treatment. The FDA will continue to investigate and analyze data from long-term studies of the potentially dangerous drugs.

Gabriel Mejia, Esq. is a Coral Springs personal injury attorney handling accident and injury cases in Florida for Law Offices Cytryn and Velazquez, P.A.

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