FDA Approves Safety Labeling Changes for Fluorouracil Injection Products

March 22, 2024

On March 21, 2024, the U.S. Food and Drug Administration (FDA) approved (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-safety-labeling-changes-regarding-dpd-deficiency-fluorouracil-injection-products) safety labeling changes regarding dihydropyrimidine dehydrogenase (DPD) deficiency for fluorouracil injection products. The update was a collaboration between FDA’s Office of Generic Drugs and the Oncology Center of Excellence (OCE).

FDA update

Since fluorouracil injection’s initial approval in 1962, additional safety information has emerged regarding the risk of serious adverse reactions related to fluorouracil use in patients with DPD deficiency. To address the safety issue, FDA revised the highlights and sections 5 (warnings and precautions) and 17 (patient counseling information) of the full prescribing information to provide information about the risks. FDA also added a subsection 12.5 (pharmacogenomics) to section 12 (clinical pharmacology). The labeling changes align with those approved for another fluoropyrimidine drug, capecitabine tablets, on December 14, 2022.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) or by calling 800-FDA-1088.

For assistance with single-patient applications for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate (https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate) at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov (mailto:OncProjectFacilitate@fda.hhs.gov).

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