Enbrel Gets "Black Box" Warning
Biologic Drug's Infection Risk Warning Strengthened to "Black Box" Warning
By Miranda Hitti
WebMD Medical NewsReviewed by Louise Chang, MDMay 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 rare cases of 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.

The biologic drugs Remicade and Humira, which are used to treat rheumatoid arthritis, already have boxed warnings about tuberculosis risk.

"Recently we decided that even though TB is uncommon with Enbrel, cases do occur, and we thought it made sense to treat all three products the same by putting a boxed warning on the Enbrel label as well," FDA spokeswoman Karen R. Mahoney tells WebMD in an email. "We hope that screening for TB will further reduce the already low rate of TB with Enbrel."

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.