FDA: Requires Stronger Class Warnings For TNF Blocker Drugs
05 August 2009 - 4:05AM
Dow Jones News
The Food and Drug Administration said Tuesday there's an
increased risk of lymphoma and other cancers associated with the
use of drugs like Remicade and Humira for children and
adolescents.
The agency said a new cancer-related warning will be added to
the boxed-warning that's already on the drugs, which are known as
tumor necrosis factor, or TNF blockers.
The drugs, which also include Enbrel, Cimzia and Simponi, are
approved to treat various immune system diseases including juvenile
idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis,
plaque psoriasis, Crohn's disease and ankylosing spondylitis.
The drug labels previously discussed a possible risk of cancer.
The drugs suppress the immune system by blocking TNF, a substance
in the body that causes inflammation and can lead to various
immune-system related diseases.
The FDA said it was working with manufacturers - including a
unit of Johnson & Johnson (JNJ), which makes Remicade, Abbott
(ABT), the maker of Humira and Amgen (AMGN) and Wyeth (WYE) which
co-market Enbrel - to define the risk of cancer in children and
adolescents.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com