Floxuridine Pregnancy and Breast Feeding Warnings

Floxuridine is also known as: FUDR

Overview

Floxuridine may cause harm to the human fetus. Avoid becoming pregnant while using Floxuridine . If you think you may be pregnant, discuss with your doctor the benefits and risks of using Floxuridine during pregnancy. It is unknown if Floxuridine is excreted in breast milk. Do not breast-feed while taking Floxuridine .

Floxuridine Pregnancy Warnings

Floxuridine has been assigned to pregnancy category D by the FDA. 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 floxuridine 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 should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

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.

Floxuridine Lactation Warnings

There are no data on the excretion of floxuridine into human milk. Because floxuridine inhibits DNA and RNA synthesis, nursing is not recommended while receiving this drug.

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