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FDA: Safety Labeling Changes on Enbrel (etanercept)

Posted December 22nd, 2009 by kestrel

BOXED WARNING
Malignancy:

•Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including Enbrel.

WARNINGS
Malignancies:

•Cases of acute and chronic leukemia have been
reported in association with postmarketing TNF blocker
use in rheumatoid arthritis and other indications. Even
in the absence of TNF-blocker therapy, patients with
rheumatoid arthritis may be at higher risk (approximately 2-fold) than the general population for the
development of leukemia.
•During the controlled portions of Enbrel trials, 2
cases of leukemia were observed among 5445 (0.06 cases
per 100 patient years) Enbrel-treated patients versus 0
among 2890 (0%) control patients (duration of controlled
treatment ranged from 3 to 48 months).
•Among 15,401 patients treated with Enbrel in controlled
and open portions...

Pediatric Patients:

•Malignancies, some fatal, have been reported among children, adolescentreceived treatment with TNF-blocking agents (initiation of therapy at < 18 years Enbrel. Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma...
•In clinical trials of 696 patients, representing 1282 patient-years of therapy, noincluding lymphoma or NMSC, have been reported...

MEDICATION GUIDE

•Updated risk of malignancies in pediatric patients, leukemia in adults, and psoriasis-like lesions associated with use of products within the class of TNF-blockers.

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