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Fluorouracil Pregnancy and Breastfeeding Warnings

Fluorouracil is also known as: Adrucil

Fluorouracil Pregnancy Warnings

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.

Fluorouracil has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryolethality and increased fetal resorptions. In monkeys, maternal doses higher than 40 mg/kg resulted in abortion of all embryos exposed to fluorouracil. Although there are no controlled data in human pregnancy, normal newborns have been delivered to women who were exposed to fluorouracil during pregnancy. However, there have been a few case reports of teratogenicity in fetuses and some live births. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Fluorouracil should only be given during pregnancy when benefit outweighs risk.

See references

Fluorouracil Breastfeeding Warnings

There are no data on the excretion of fluorouracil into human milk. Because fluorouracil inhibits DNA, RNA and protein synthesis, mothers should not nurse while receiving this drug.

See references

References for pregnancy information

  1. "Product Information. Fluorouracil injection (fluorouracil)." Roche Laboratories, Nutley, NJ.
  2. 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 137 (1980): 747-9
  3. Stadler HE, Knowles J "Fluorouracil in pregnancy: effect on the neonate." JAMA 217 (1971): 214-5
  4. Sutton R, Buzdar AU, Hortobagyi GN "Pregnancy and offspring after adjuvant chemotherapy in breast cancer patients." Cancer 65 (1990): 847-50
  5. "Product Information. FUDR Sterile (floxuridine)." Roche Laboratories, Nutley, NJ.
  6. Dreicer R, Love RR "High total dose 5-fluorouracil treatment during pregnancy." Wis Med J 90 (1991): 582-3
  7. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):

References for breastfeeding information

  1. "Product Information. Fluorouracil injection (fluorouracil)." Roche Laboratories, Nutley, NJ.
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):

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