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Diclofenac / fluorouracil topical Pregnancy and Breastfeeding Warnings

Diclofenac / fluorouracil topical is also known as: Fluorac

Diclofenac / fluorouracil topical Pregnancy Warnings

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.

Use is contraindicated.

US FDA pregnancy category Not Assigned

-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.

See references

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.

See references

References for pregnancy information

  1. "Product Information. Fluorac (diclofenac-fluorouracil topical)." Burke Therapeutics (2015):

References for breastfeeding information

  1. "Product Information. Fluorac (diclofenac-fluorouracil topical)." Burke Therapeutics (2015):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.