Diclofenac / fluorouracil topical Pregnancy and Breastfeeding Warnings

Brand names: Fluorac

Diclofenac / fluorouracil topical Pregnancy Warnings

Use is contraindicated.

US FDA pregnancy category Not Assigned

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the fetus.

Animal studies have shown that parenteral administration is teratogenic. Cleft lip and palate birth defects have been reported in the newborn of a patient using topical fluorouracil. Ventricular septal defects and cases of miscarriage have been reported when topical fluorouracil was applied to mucous membrane areas. Multiple birth defects have been reported in a fetus of a patient treated with intravenous fluorouracil. There are no adequate and well-controlled studies in pregnant women with either the topical or the parenteral forms of this drug.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

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Diclofenac / fluorouracil topical Breastfeeding Warnings

A decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

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Further information

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