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FDA Performing Safety Review of TNF Blockers

Review due to reports of cancer in young patients taking tumor necrosis factor blockers

WEDNESDAY, June 4 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) is performing a safety review of drugs that block tumor necrosis factor (TNF), used to treat diseases such as arthritis and psoriasis, due to reports of cancers in young patients prescribed the drugs.

FDA officials note that approximately 30 cases of cancer in children and young adults have been reported to their Adverse Event Reporting System between 1998 (after the first TNF blocker was approved) and 2008. The cancers occurred in individuals who began taking the drugs (and other immunosuppressive drugs) at the ages of 18 years or younger to treat diseases such as Juvenile Idiopathic Arthritis and Crohn's disease.

About half the cancers were lymphomas, both Hodgkin's and non-Hodgkin's, which the FDA notes are not recognized complications of Juvenile Idiopathic Arthritis or Crohn's disease. Other cancers included leukemia, melanoma and solid organ cancers. Four TNF blockers are currently available in the United States -- Remicade, Enbrel, Humira and Cimzia -- and their prescribing information already indicates the risk of cancer.

"At the current time, the FDA believes that the potential benefits of the use of TNF blockers outweigh the potential risks in certain children and young adults having one of the diseases for which the TNF blockers are approved to treat," according to FDA officials.

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