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

Listen to this Podcast

Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today's topic: UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy.

Joan Powers, a Consumer Safety Officer in the Division, will provide you with additional information about this Communication.

Guest Speaker: On November 3, 2011, the Food and Drug Administration issued a Drug Safety Communication updating the public about its ongoing safety review of Tumor Necrosis Factor, or TNF, blockers and malignancy 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.

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 at www.fda.gov/medwatch 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, such as age and gender with 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, such as duration and dose
  • cancer diagnosis, date of diagnosis, and stage
  • biopsy results
  • outcomes of malignancy, such as treatments and 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.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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