FDA has informed healthcare professionals that it is investigating a possible association between drugs that block tumor necrosis factor (TNF) and the development of lymphoma and other cancers in children and young adults.
This is part of FDA’s commitment to inform healthcare professionals and the public about its ongoing drug safety reviews. Because this information is preliminary and there is scientific uncertainty, FDA is not taking regulatory action at this point, nor advising healthcare professionals to stop using the drugs.
The TNF blockers in question, Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab) and Cimzia (certolizumab pegol), are used to treat juvenile idiopathic arthritis, Crohn’s disease, and other inflammatory conditions. The labeling for these drugs already warns about a possible risk of cancer.
Over the past ten years, FDA has received about 30 reports of cancer in patients who were treated with TNF blockers when they were under 18 years old. These patients also took other immunosuppressive agents, such as methotrexate and azathioprine. Although these reports are cause for concern, in and of themselves they do not establish that TNF blockers increase the risk of cancer above background levels.
FDA is investigating all the available evidence about a possible link between TNF blockers and cancer, and is consulting with experts in this area to determine whether there are children with juvenile idiopathic arthritis and Crohn’s disease who may be at special risk of developing cancer if they take the drugs. This evaluation will take about six months, after which FDA will let health professionals and the public know about its conclusions.
In the meantime, health care professionals, parents and caregivers should be aware of the possible cancer risk in deciding the best way to treat these patients. FDA also encourages both healthcare professionals and patients to report side effects from the use of Remicade, Enbrel, Humira, and Cimzia, to the FDA’s MedWatch adverse event reporting program.
Again, this is preliminary information and it is part of FDA’s effort to keep the public informed about its ongoing drug safety reviews.
Additional Information:
FDA MedWatch Safety Alert. Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia). June 3, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF
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