Kids and teens treated with drugs called tumor necrosis factor (TNF) blockers may be at an increased risk for lymphoma and other cancers, according to the US Food and Drug Administration (FDA), which is updating black box warnings for the drugs.
The FDA's decision is based on a yearlong review of the childhood cancer risk associated with TNF blocker drugs, which are used to treat rheumatoid arthritis, Crohn's disease, and other inflammatory diseases.
These drugs* -- which include adalimumab (Humira), etanercept (Enbrel), certolizumab pegol (Cimzia), golimumab (Simponi), and infliximab (Remicade) -- work by blocking tumor necrosis factor, a protein that's overproduced in some immune system diseases. The FDA started investigating the drugs in 2008 after evidence suggested that interfering with TNF may also increase the risk of some life-threatening infections and certain cancers.
The FDA’s safety review and analysis is based on 48 cases of malignancies – including lymphoma and other cancers – in children and adolescents treated with TNF inhibitors. This analysis found children and teens taking these drugs had an increased risk of cancer, with cases occurring on average after 30 months of treatment. About half were lymphomas, and some were fatal.
TNF therapies are improving the lives of millions of Americans and they are important treatment options for people with inflammatory forms of arthritis, such as JIA. The Arthritis Foundation concurs that additional data and further analysis are needed, however, to determine whether malignancies are a direct result of TNF blocker use. Whether treated with biologics or not, some types of arthritis may increase the risk for developing cancer. Other drug and non-drug factors that may contribute to this risk include suppression of the immune system, use of multiple immunosuppressive therapies, long-term drug treatment and higher dosages.
The FDA said it was working with TNF drug manufacturers, including Johnson & Johnson, Abbott, and Wyeth, to better understand the childhood cancer risk associated with these drugs.
If your child is taking or considering taking a TNF blocker, discuss the risks and potential benefits with your doctor.
Cancers in children often are hard to recognize. Parents should be sure that their children have regular medical check-ups and watch for any unusual signs or symptoms that do not go away. These may include:
- an unusual lump or swelling
- unexplained paleness and loss of energy easy bruising
- an ongoing pain in one area of the body
- limping
- unexplained fever or illness that doesn't go away
- frequent headaches, often with vomiting
- sudden eye or vision changes
- sudden unexplained weight loss
The concern about adverse side effects with TNF blockers further emphasizes the need for a national registry for patients with JIA as well as a network of collaborating treatment centers to ensure that full information can be acquired about the risks and benefits of arthritis therapies. The Arthritis Foundation is working toward this goal through its support for the Childhood Arthritis & Rheumatology Research Alliance (CARRA). CARRA is a North American organization of pediatric rheumatologists who have joined together to answer critical clinical research questions and determine the best possible treatment options for childhood arthritis and other childhood rheumatic diseases.
For more information about TNF blockers and the new black box warnings, visit the FDA's web site.
* The FDA’s analysis on pediatric malignancies included TNF inhibitors Remicade and Enbrel. It did not include Humira, which rarely is used to treat children, nor Cimzia or Simponi, which are not yet approved for use in children.
