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Fluorouracil topical Pregnancy and Breastfeeding Warnings

Fluorouracil topical is also known as: Carac, Efudex, Efudex Occlusion Pack, Fluoroplex

Fluorouracil topical Pregnancy Warnings

Fluorouracil topical has been assigned to pregnancy category X by the FDA. Animal studies with injectable and intraperitoneal fluorouracil have revealed evidence of teratogenicity and embryotoxicity (increased resorption, abortion, or embryolethality). There are no controlled data in human pregnancy; however, birth defects have been reported with the topical and parenteral forms of fluorouracil. The use of fluorouracil topical is contraindicated in women who are pregnant or may become pregnant during treatment. Patients should be advised of the potential risk to the fetus.

A ventricular septal defect and miscarriages have been reported when fluorouracil topical was applied to mucous membranes. A cleft lip and palate have been reported when fluorouracil topical was administered as recommended. The fetus of a patient treated with intravenous fluorouracil developed multiple birth defects.

Fluorouracil topical Breastfeeding Warnings

There are no data on the excretion of fluorouracil topical into human milk. Because 5% to 6% of a topical fluorouracil dose is systemically absorbed, and because many drugs are excreted in milk, the manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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