Floxuridine Pregnancy and Breastfeeding Warnings
Brand names: FUDR
Medically reviewed by Drugs.com. Last updated on Aug 30, 2023.
Floxuridine Pregnancy Warnings
This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
US FDA pregnancy category: D
Animal studies have revealed evidence of teratogenicity. Malformations have included cleft palates, skeletal defects, and deformed appendages, paws, and tails. There are no controlled data in human pregnancy. No cases of human teratogenicity due to this drug have been reported. However, human teratogenicity has been reported with the use of drugs which inhibit DNA synthesis such as fluorouracil, methotrexate, and aminopterin.
Floxuridine is catabolized to fluorouracil. The use of intravenous fluorouracil in the first trimester resulted in multiple defects (radial aplasia; absent thumbs and fingers; hypoplasia of lungs, aorta, thymus, and bile duct; aplasia of esophagus, duodenum, and ureters; single umbilical artery; absent appendix; imperforate anus; a cloaca) in an aborted fetus. Other toxicities reported include cyanosis and jerking extremities in a newborn exposed to fluorouracil in the third trimester.
Fluorouracil has been reported to induce chromosomal aberrations and changes in chromosome organization of spermatogonia in animals. Spermatogonial differentiation was also inhibited by fluorouracil, resulting in transient infertility in animals.
US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Floxuridine Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comment: This drug has the potential to harm a nursing infant because it inhibits DNA and RNA synthesis.
See also
References for pregnancy information
- Stadler HE, Knowles J. Fluorouracil in pregnancy: effect on the neonate. JAMA. 1971;217:214-5.
- Stephens JD, Golbus MS, Miller TR, Wilber RR, Epstein CJ. Multiple congenital anomalies in a fetus exposed to 5-fluorouracil during the first trimester. Am J Obstet Gynecol. 1980;137:747-9.
- Sutton R, Buzdar AU, Hortobagyi GN. Pregnancy and offspring after adjuvant chemotherapy in breast cancer patients. Cancer. 1990;65:847-50.
- Dreicer R, Love RR. High total dose 5-fluorouracil treatment during pregnancy. Wis Med J. 1991;90:582-3.
- Product Information. Fluorouracil (fluorouracil). Roche Laboratories. 2022.
- Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. Baltimore, MD: Williams & Wilkins. 1998.
- Product Information. FUDR (floxuridine). Roche Laboratories. 2022.
References for breastfeeding information
- Product Information. FUDR (floxuridine). Roche Laboratories. 2022.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
