Enbrel Gets Black Box Warning

Scott Kappes

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This week Amgen and Wyeth updated the warning label for their rheumatoid arthritis medication, Enbrel, to inform healthcare professionals and patients of an increased risk of infection associated with the drug. The drug already carried a risk of infection warning; however, the update expands this warning to include information about screening and monitoring patients for tuberculosis (TB). In analysis of more than 20,000 patients worldwide TB was observed in 0.01 percent of patients.

The medication inhibits tumor necrosis factor (TNF), a protein involved in inflammation. But the drug can also interfere with the body's ability to fight infections. Enbrel is approved for adult use in several conditions, and for kids 2 and older who have juvenile idiopathic arthritis.

While the risk is small patients and healthcare professionals should be informed about this elevated risk. Enbrel accounted for over three billion in sales last year for Amgen and was responsible for an additional two billion in sales for Wyeth. The manufacturers have been under fire from healthcare authorities over allegations of off-label marketing tactics.