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The Food and Drug Administration approved the popular but controversial arthritis drug Remicade on Friday for use in children with Crohn''s disease. The approval comes just two days after a study linked the drug to an increased risk for malignancies and serious infections.
Despite reports of an aggressive and often fatal form of lymphoma in adolescents and young adult Crohn''s patients taking Remicade, the FDA said potential benefits outweigh the risks associated with this drug.
Remicade received initial FDA approval in 1998 for the treatment of rheumatoid arthritis and Crohn''s disease in adults. Since that time, the drug has been linked to a number of dangerous, potentially deadly, conditions.
Last Wednesday, a study conducted by researchers at the Mayo Clinic appeared in the Journal of the American Medical Association that found a link between Remicade and another drug, Humira, and certain cancers and infections in rheumatoid arthritis patients.
The current labeling on Remicade warns of an increased risk of lymphoma, serious infections such as tuberculosis, and various blood and central nervous system disorders.
However, the Mayo Clinic study found that patients taking the drug faced an additional risk – three times in fact – for developing cancers including skin, gastrointestinal, breast, and lung tumors.
The risk for serious infections like pneumonia and cellulitis in patients taking Remicade is double, according to the recent study. Prior research has also linked the drug to serious liver damage.
Centocor, a Johnson & Johnson subsidiary, makes the drug, which acts as an immunosuppressant, blocking a protein linked to inflammation. Both Crohn''s disease and rheumatoid arthritis are autoimmune diseases that cause painful inflammation.
The FDA said it was working with Centocor to revise the warnings on the drug''s label.
More Remicade News
May 17, 2006 - "Remicade and Humira Increase Cancer Risk"
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