Fluorouracil may cause fetal harm when administered to a pregnant woman. Fluorouracil
is contraindicated in women who are or may become pregnant. If this drug is
used during pregnancy, or if the patient becomes pregnant while taking this
drug, the patient should be apprised of the potential hazard to the fetus.
No adequate and well-controlled studies have been conducted in pregnant women
with either topical or parenteral forms of fluorouracil. One birth defect (ventricular
septal defect) and cases of miscarriage have been reported when fluorouracil
was applied to mucous membrane areas. Multiple birth defects have been reported
in the fetus of a patient treated with intravenous fluorouracil.
Animal reproduction studies have not been conducted with Carac. Fluorouracil,
the active ingredient, has been shown to be teratogenic in mice, rats, and hamsters
when administered parenterally at doses greater than or equal to 10, 15 and
33 mg/kg/day, respectively, [4X, 11X and 20X, respectively, the Maximum Recommended
Human Dose (MRHD) based on body surface area (BSA)]. Fluorouracil was administered
during the period of organogenesis for each species. Embryolethal effects occurred
in monkeys at parenteral doses greater than 40 mg/kg/day (65X the MRHD based
on BSA) administered during the period of organogenesis.
Carac (fluorouracil) should not be used in patients with dihydropyrimidine dehydrogenase (DPD)
enzyme deficiency. A large percentage of fluorouracil is catabolized by the
enzyme dihydropyrimidine dehydrogenase (DPD). DPD enzyme deficiency can result
in shunting of fluorouracil to the anabolic pathway, leading to cytotoxic activity
and potential toxicities.
Carac (fluorouracil) is contraindicated in patients with known hypersensitivity to any of
its components.
Last reviewed on RxList: 11/10/2008
This monograph has been modified to include the generic and brand name in many instances.