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Enbrel Black Box Warns of Tuberculosis Risk

May 1, 2008 | Parker Waichman Alonso LLP

Enbrel, a drug used to treat psoriasis that has been associated with serious infections, including tuberculosis in some patients.  Enbrel's labeling will now carry the Food & Drug Administration's (FDA) strictest safety notice, a black box warning.

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.

The new Enbrel black box warning was prompted by 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.  Enbrel and other medicines in the same class work by blocking a type of immune system protein.  

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. The 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 Enbrel Patient Package Insert is also being converted to a Medication Guide. The Medication Guide is designed to provide important patient safety information and increase the awareness about the proper use of Enbrel. The companies said that the Medication Guide will be distributed when a prescription for Enbrel is dispensed in the US.