Enbrel Gets "Black Box" Warning
Biologic Drug's Infection Risk Warning Strengthened to "Black Box" Warning
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
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
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.