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FDA Investigating Remicade, Enbrel, Humira and Cimzia Link to Cancers

The U.S. Food and Drug Administration (FDA) has issued an Early Communication release stating that it is investigating a possible association between tumor necrosis factor (TNF) blockers and the development of cancers in children and young adults. The TNF blockers were prescribed to treat Juvenile Idiopathic Arthritis (JIA), Crohn's disease or other diseases.

Remicade, developed by Centocor, Inc., is currently manufactured by Schering-Plough Corp. Enbrel is made by Wyeth, Humira is made by Abbott Laboratories, and Cimzia is made by UCB SA. According to the Associated Press, the TNF blockers are key revenue drivers for the companies. Humira was Abbott's best-selling product last year with over $3 billion in sales. Remicade led Schering-Plough's sales at $1.65 billion.

According to the news release, the FDA is investigating approximately 30 reports submitted to its Adverse Event Reporting System over a ten-year interval, beginning in 1998 and extending through April 29, 2008. These reports described cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less.

Remicade, Enbrel, Humira and Cimzia Legal Help

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Last updated on Jun-5-08


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