FDA continues safety review of TNF blockers and pediatric malignancies

The FDA announced this week that it is requiring the manufacturers of tumor necrosis factor blockers to perform enhanced safety surveillance for these products.

The FDA is conducting an ongoing safety review of tumor necrosis factor (TNF) blockers and malignancy in children, adolescents and adults aged 30 years or younger, according to an agency press release.

As part of the enhanced safety surveillance, the drug manufacturers are conducting in-depth follow-up of malignancy cases. The case reports will all be submitted to the FDA as expedited reports (within 15 days of becoming aware of the report) for pediatric and young adult patients.

The manufacturers will also provide the FDA with annual summaries and assessments of malignancies and TNF blocker utilization data. FDA officials said this type of safety surveillance is designed to improve the understanding of malignancies in pediatric and young adult patients treated with TNF blockers because it will allow the FDA to more completely capture and analyze all reported malignancies based on more complete and consistent reports, according to the release.

The agency is advising health care professionals to remain vigilant for cases of malignancy in patients treated with TNF blockers and report them to the FDA MedWatch program or to the manufacturer. For more information, visit www.fda.gov.

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