Warning on lymphoma risk with TNF blockers


The manufacturers of the drugs Humira ( adalibumab ), Remicade ( infliximab ) and Enbrel ( etanercept ) have added new safety information to the labels for these products about malignancies.
These three drugs are tumor necrosis factor ( TNF ) blocking agents, and they're used to treat rheumatoid arthritis and other autoimmune diseases.

In controlled studies of TNF blockers, more cases of lymphoma occurred among patients receiving the agents than among control patients. And in open-label, uncontrolled clinical studies, the rate of malignancies in patients treated with TNF blockers was several times higher than would be expected in the general population. These uncontrolled studies can't establish a causal relationship between the TNF blockers and the excess malignancies, because patients with highly active autoimmune disease may be at increased risk for lymphoma, independent of the drugs they're taking.

Source : FDA; 2004

XagenaMedicine2005