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FDA Drug Safety Communication: UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy

This information is an update to the FDA Drug Safety Communication: Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine issued on April 14, 2011.

[11-03-2011] The U.S. Food and Drug Administration (FDA) is updating the public about its ongoing safety review of Tumor Necrosis Factor (TNF) blockers and malignancy (cancer) in children, adolescents, and young adults (30 years of age or younger). FDA is requiring the manufacturers of TNF blockers to perform enhanced safety surveillance for these products. 

What are TNF blockers?
  • A class of biologic products that are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis
  • TNF blockers include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab).

The enhanced safety surveillance will consist of the manufacturers conducting in-depth follow-up of reports of malignancy cases, and submitting all reports of malignancy to FDA as expedited reports (within 15 days of becoming aware of the report) for pediatric and young adult patients. The manufacturers will also provide FDA with annual summaries and assessments of malignancies and TNF blocker utilization data. This type of safety surveillance is important for our improved understanding of malignancies in pediatric and young adult patients treated with TNF blockers because it will allow FDA to more completely capture and analyze all reported malignancies based on more complete and consistent reports. 

Healthcare professionals should remain vigilant for cases of malignancy in patients treated with TNF blockers and report them to the FDA MedWatch program (see the information in the "Contact Us" box at the bottom of this page) or to the manufacturer. Healthcare professionals may be queried by FDA or the manufacturer for additional clinical and diagnostic information related to the malignancy cases. Information collected will include:

  • patient characteristics (age, gender, no patient identifiers)
  • risk factors for malignancy
  • exposure to other immune suppressing products or products with risk of malignancy
  • indication for TNF blocker treatment
  • TNF blocker exposure (duration, dose)
  • cancer diagnosis (date of diagnosis, stage)
  • biopsy results
  • outcomes of malignancy (treatments, event outcome)

The enhanced surveillance requirement will be re-evaluated periodically by FDA over the next ten years.

FDA previously communicated about reports of malignancy associated with TNF blockers in June 2008, August 2009, and April 2011.

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