FDA: Requires Stronger Class Warnings For TNF Blocker Drugs

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; [e-mail]