FDA mandates enhanced safety check on TNF blockers

December 1, 2011

FDA is requiring that manufacturers of tumor necrosis factor blockers perform enhanced safety surveillance in children, teenagers, and young adults, the agency said on November 3 in an ongoing safety review of this class of biologic products.

FDA is requiring that manufacturers of tumor necrosis factor (TNF) blockers perform enhanced safety surveillance in children, teenagers, and young adults, the agency said on November 3 in an ongoing safety review of this class of biologic products.

Manufacturers are expected to conduct thorough follow-up of reports of malignancy cases involving TNF blockers and submit all reports of malignancy to FDA as expedited reports (within 15 days) for pediatric and young adult patients (aged 30 years or younger). Manufacturers also will provide annual summaries and assessments of malignancies and TNF blocker utilization data to FDA.

This type of safety surveillance is important for the improved understanding of malignancies in pediatric and young adult patients treated with TNF blockers. It will allow FDA to capture and analyze all reported malignancies based on more complete, consistent reports, the agency said.

Healthcare workers should remain vigilant for cases of malignancy in patients treated with TNF blockers and report them to the FDA MedWatch program or manufacturer.

FDA will re-evaluate the enhanced surveillance requirement periodically during the next 10 years.