Fluorouracil Pregnancy and Breast Feeding Warnings
Fluorouracil is also known as: Adrucil
Overview
Fluorouracil has been shown to cause harm to the human fetus. If you plan on becoming pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluorouracil while you are pregnant. It is not known if Fluorouracil is found in breast milk. Do not breast-feed while taking Fluorouracil .
Fluorouracil Pregnancy Warnings
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.
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 Lactation 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.
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