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08/12/2009 - News

FDA Updates Cancer Warnings for TNF Blockers

By: June Chen, MD

Last week, the U.S. Food and Drug Administration (FDA) issued an alert requiring stronger warnings regarding the cancer risk associated with tumor necrosis factor (TNF) blockers, drugs used for the treatment of inflammatory diseases such as Crohn disease and juvenile rheumatoid arthritis.

The new warning for TNF blockers will include an updated boxed warning, and it will highlight the increased risk for cancer in children and adolescents who take TNF blockers. Based on an investigation of TNF blockers that was initiated by the FDA in June 2008, the increased risk for cancer was reported, on average, after 30 months of treatment with TNF blockers. The most common cancer type reported, accounting for about half of all cancers, was lymphoma.
The updated boxed warning for TNF blockers will also include information describing reported cases of leukemia in all age groups, as well as additional information on cancers in children and adolescents. The warning will also incorporate information on the risk of psoriasis in conjunction with the use of TNF blockers such as infliximab (marketed as Remicade®), etanercept (marketed as Enbrel®), adalimumab (marketed as Humira®), certolizumab pegol (marketed as Cimzia®), and golimumab (marketed as Simponi®).


U.S. Food and Drug Administration website, accessed August 5, 2009.

Created on: 08/12/2009
Reviewed on: 08/12/2009

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