DBL Fluorouracil Use In Pregnancy & Lactation

Use in pregnancy - Category D: Fluorouracil may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. Fluorouracil administered parenterally has been shown to be teratogenic in mice, rats and hamsters, and embryolethal in monkeys. Fluorouracil is strictly contraindicated in pregnancy (see Contraindications).
Safety for use in pregnancy has not been established. Women of childbearing age should be advised to avoid pregnancy during fluorouracil therapy. Fluorouracil should only be used in women of childbearing potential if the expected benefits outweigh the risks of therapy, and adequate contraception is used. If the patient becomes pregnant whilst receiving the drug, the patient should be advised of the potential hazards on the fetus. Men undergoing fluorouracil treatment should also ensure they use effective contraceptive measures.
Use in lactation: It is not known whether fluorouracil is excreted in breast milk. To avoid possible harmful effects in the infant, breast-feeding is not advised during fluorouracil therapy.