FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products
Regulatory approval: On March 21, 2024, the FDA approved safety labeling changes for fluorouracil injection products to address the risk of serious adverse reactions in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. Updates were made to the Highlights and full Prescribing Information (Warnings and Precautions; Patient Counseling) and a new Pharmacogenomics subsection was added. The changes align with labeling updates previously approved for capecitabine (Xeloda) in 2022.
FDA labeling update for fluorouracil injection: DPD deficiency risk (regulatory approval)
On March 21, 2024, the FDA approved safety labeling changes for fluorouracil injection products. The update was a collaboration between the FDA’s Office of Generic Drugs and the Oncology Center of Excellence (OCE).
According to the FDA, it became aware of additional safety information regarding the risk of serious adverse reactions associated with fluorouracil use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency.
Labeling revisions were made to:
- Highlights of Prescribing Information
- Full Prescribing Information Section 5 (Warnings and Precautions)
- Full Prescribing Information Section 17 (Patient Counseling Information)
In addition, a new Section 12.5 (Pharmacogenomics) subsection was added within Section 12 (Clinical Pharmacology) to provide information about these risks.
The FDA noted that these labeling changes align with those approved for capecitabine (Xeloda) tablets on December 14, 2022.
The FDA encouraged reporting of serious suspected adverse events to MedWatch (or 1-800-FDA-1088).