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May 1, 2008 -- The arthritis and psoriasis drug Enbrel now has a "black box" warning about the risk of serious infections that may lead to hospitalization or death.
Enbrel is used to treat rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis. It already carried a warning about infection risk. Now, those risks appear in a "black box" warning, the FDA's sternest warning.
The new black box warning notes that infections seen in patients treated with Enbrel have included bacterial sepsis and tuberculosis. The warning recommends teaching patients taking Enbrel about infection symptoms, monitoring them for infection during and after treatment with Enbrel, and screening them for tuberculosis before and during Enbrel treatment.
Amgen and Wyeth, the drug companies that make Enbrel, wrote a letter to doctors in March to tell them about Enbrel's black box warning. That letter now appears on the FDA's web site.