The Food and Drug Administration (FDA) is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers used to treat arthritis, psoriatic arthritis and other inflammatory diseases, because they can increase the risk of cancer in children and adolescents.
The agency said a new cancer-related warning will be added to the boxed-warning that's already on the drugs. The boxed warning, the FDA's strongest drug warning, currently warns of the risk of developing serious infections that can be fatal.
TNF blockers work by neutralizing a protein that, when overproduced causes inflammation and damage to bones, cartilage and other tissue.
The drugs in this class include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).
Today’s action is the result of a safety review of TNF blockers launched by the agency last June after receiving 30 reports of cancer in children and young adults under the age of 18, over a 10-year period who had been treated with one of these drugs and other like drugs. About half the cancers were lymphomas, a cancer of cells in the immune system, and included both Hodgkin's and non-Hodgkin's lymphoma. Some of the reported cancers were fatal.
The FDA is working with manufacturers – including Johnson & Johnson, which makes Remicade and Simponi, as well as others to define the risk of cancer in children and adolescents. #