September 1, 2009 — The US Food and Drug Administration (FDA) ruled
yesterday that Boxed Warnings on the labeling of the tumor necrosis factor
(TNF) blockers Remicade (infliximab), Humira(adalimumab), Cimzia (certolizumab),
Enbrel (etanercept), andSimponi (golimumab) be expanded to include a
warning of an increased risk for lymphoma and other cancers in children
and adolescents taking these drugs.
The FDA is also requiring a more general warning of an increased risk for
leukemia and new-onset psoriasis associated with the use of TNF blockers.
The Medication Guides for patients taking TNF blockers will be updated to
include more detailed information about the cancer risks.
The current prescribing information, last updated August 4, 2009, contains a
warning of an increased risk for malignancies, but leukemia is not specified.
A total of 48 American and non-American cases of pediatric malignancies associated
with TNF blocker use have been reported. No dose association has been established.

Yesterday's update includes new Q&As about how the FDA calculated the cancer
risk and more information on the specific malignancies reported, including 15 cases
of pediatric malignancies associated with the use of infliximab and 6 cases of
pediatric malignancies associated with the use of etanercept.

BİLGİ TARAFIMIZA PRF.DR CANAN HOCAMIZ TARAFINDAN İLETİLMİŞTİR..