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Jun 5
Humira, Remicade and Enbrel Under FDA Review for Cancer Link

 

 

The U.S. Food and Drug Administration announced that it is investigating whether a group of arthritis drugs increase the risk of pediatric cancer. The group of drugs iAbbott Labsnclude Abbott Laboratories' Humira, Schering-Plough's Remicade and Enbrel by Amgen and Wyeth.

The FDA stated that it has received 30 reports of children and young adults developing cancer while taking the arthritis medications. The reports were received WyethPharma.jpgto the FDA's Adverse Event Reporting System over a 10 year period. Children with arthritis, and sometimes Crohn's disease, are prescribed these drugs to block a chemical that causes inflammation.

Pediatric ArthritisThe medications, known as necrosis factor blockers, are big money makers for the pharmaceuticals with both Humira and Remicade being their respective company's best selling prescription medication.

The FDA stated that while labels already include cancer warnings the agency will focus on the drugs' effects and risks on children. Long term studies are expected.

FDA has asked the makers of the TNF blockers approved for use in children (Remicade, Enbrel, and Humira) to provide information about all cases of cancer reported in children taking TNF blockers.  The maker of Cimzia is required 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.  FDA has contacted medical experts to assess the potential association between TNF blockers and cancers, including lymphoma, and to determine if there are children and young adults with JIA and Crohn’s disease who may be at particular risk for developing a lymphoma or other cancer. 

[Source: U.S. Food and Drug Administration]


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