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
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