FDA MedWatch - Tumor Necrosis Factor (TNF) blockers: UPDATE

[FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - Tumor Necrosis Factor (TNF) blockers: UPDATE

Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults

 

[UPDATED 11/04/2011]  Healthcare professionals should remain vigilant for cases of malignancy in patients treated with TNF blockers, and report such cases to MedWatch. The reports should 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)

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251443.htm

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