Cancers in Children Tied to TNF Blockers
The Food and Drug Administration (FDA) has announced that certain drugs prescribed to treat rheumatoid arthritis, Crohn’s disease, and other inflammatory conditions may increase the risk of cancer in children. The drugs belong to a class called tumor necrosis factor (TNF) blockers, which have the ability to hinder the activity of a protein that causes inflammation.
The FDA has ordered manufacturers of TNF blockers to include an updated “black box” warning label on their products, which cautions patients and doctors that the medications may increase the risk of cancer in children and adolescents. TNF blocker packages already have a black box warning for fungal infections and other potential problems.
The current FDA mandate follows the agency’s early communication of June 2008 in which it stated that it was “investigating the possible association between the use of medicines known as tumor necrosis factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults.”
The FDA’s review of the use of TNF blockers, which include adalimumab (Humira®), certolizumab pegol (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®), and infliximab (Remicade®), concluded that the drugs were associated with an increased risk of lymphoma, leukemia, and other cancers in children. The reviewers noted that the cancers tended to emerge about 30 months after the children starting taking the medications. About 50 percent of the children’s cancers were lymphomas, a cancer of the cells of the immune system, and some of the children died.
It has been known for some time that people who have inflammatory conditions such as rheumatoid arthritis and Crohn’s disease are already at an increased risk for cancer. Now the TNF blockers used to treat these conditions may increase the risk as well. For now, parents of children who have inflammatory conditions and who take TNF blockers need to consult with their physicians to weigh the risks and benefits of the drugs and consider the possibility that they may cause cancer in their children.
FDA Early Communication, June 4, 2008
FDA Release, August 4, 2009
Wall Street Journal