The FDA ( Food and Drug Administration ) is requiring the manufacturers of TNF blockers to update the Boxed Warning in the prescribing information to alert healthcare professionals of an increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers.

In addition to the updated Boxed Warning, FDA is requiring several other changes to the prescribing information for TNF blockers to warn of and mitigate the risks associated with these drugs. These changes are based on additional safety reviews and include a(n):

a) Update to the Warnings section describing reported cases of leukemia in adults, adolescents, and children. Changes to the Warnings section of the labeling will also include additional information on malignancies in children and adolescents.

b) Update to the Adverse Events section to include information on reported cases of new-onset psoriasis.

This new safety information is based on FDA’s completed analysis of TNF blockers and reports of lymphoma and other cancers in children and adolescents, a second analysis of TNF blockers and post-marketing leukemia reports in all patients, as well as a post-marketing evaluation of new-onset psoriasis in patients treated with these drugs.

The drugs in this class include Remicade ( Infliximab ), Enbrel ( Etancercept ), Humira ( Adalimumab ), Cimzia ( Certolizumab pegol ) and Simponi ( Golimumab ).

TNF blockers are approved for the treatment of one or more of a number of immune system diseases including ankylosing spondylitis, rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, and Crohn’s disease.

Source: FDA, 2009

XagenaMedicine2009


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