FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products

On March 21, 2024, the Food and Drug Administration (FDA) approved safety labeling changes for fluorouracil injection products. Revisions to the labeling note increased warning of severe toxicity in patients with dihydropyrimidine dehydrogenase (DPD) deficiency and encourages clinicians to discuss DPYD testing and associated risks with their patients. Additionally, a new subsection for pharmacogenomics was added to section 12 (Clinical Psychology). This effort was a collaboration between FDA’s Office of Generic Drugs and the Oncology Center of Excellence (OCE).

Read the full news post on the FDA website.

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