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New Tuberculosis Warning for Enbrel

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Enbrel, a drug used to treat psoriasis and rheumatoid arthritis, now has a new black box warning because of its association with tuberculosis and other infections. The new Enbrel black box warns physicians to monitor patients receiving Enbrel for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection. The drug’s makers, Amgen and Wyeth, said the Enbrel Patient Package Insert is also being converted to a Medication Guide.

The Food & Drug Administration (FDA) asked for the new black box warning after global studies of over 20,000 patients taking Enbrel, where tuberculosis was observed in about 200 people. Approximately 14,000 Americans were diagnosed with tuberculosis last year. Tuberculosis is a bacterial lung infection, and according to the federal Centers for Disease Control and Prevention (CDC), people with weakened immune systems are more likely to contract the disease.

The new Enbrel label says that patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection prior to starting and during treatment with Enbrel. In cases of latent tuberculosis infection, treatment should be initiated prior to therapy with Enbrel. The Enbrel black box warning also says some patients who tested negative for latent tuberculosis prior to receiving Enbrel have developed active tuberculosis.

Enbrel, manufactured by Amgen and Wyeth, is made from a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance made by the body’s immune system called TNF. People with an immune disease, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, have too much TNF in their bodies. The FDA first approved Enbrel in 2000 for treating rheumatoid arthritis, and its approved uses where expanded several times to include psoriasis and other conditions.

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