NEWS - Enbrel gets black blox warning for TB risk

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Etanercept Gets Black Box Warning for TB Risk

May 2, 2008 — The safety labeling for etanercept (Enbrel, Amgen, Inc,

marketed by Wyeth) has been revised to include a " black box " warning

regarding the risk for serious infection that can lead to

hospitalization or death, the US Food and Drug Administration (FDA)

announced yesterday.

Reported infections have included bacterial sepsis and tuberculosis

(TB), according to an alert issued by MedWatch, the FDA's safety

information and adverse event reporting program.

The warning was based on data from global clinical studies (n =

20,070), showing the incidence of TB to be approximately 0.01% over

28,308 patient-years of etanercept therapy. US and Canadian clinical

studies (n = 15,438 and 23,524 patient-years, respectively) revealed a

TB rate of 0.007%.

Because treatment with tumor necrosis factor inhibitors, including

etanercept, increases the risk for TB reactivation, patients should be

screened for latent disease and treated before initiation of therapy.

Patients should be educated regarding infection symptoms and monitored

for TB and other infections both during and after etanercept therapy,

the FDA advised. Those who develop an infection should be evaluated

for appropriate antimicrobial therapy. For cases of serious infection,

etanercept should be discontinued.

Etanercept subcutaneous injection is indicated for the treatment of

rheumatoid arthritis, polyarticular juvenile idiopathic arthritis,

psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

Additional information regarding the use of etanercept may be obtained

by contacting Amgen's Medical Information Connection by telephone at

1-800-77-AMGEN (1-800-772-6436).

Adverse events related to etanercept therapy may be reported at the

number above or to the FDA's MedWatch reporting program by telephone

at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at

http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane,

Rockville, MD 20852-9787.

http://www.medscape.com/viewarticle/573955

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Not an MD