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Fluorouracil topical Pregnancy and Breastfeeding Warnings

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

Medically reviewed by Drugs.com. Last updated on Dec 4, 2020.

Fluorouracil topical Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: This drug can harm a developing fetus when administered to a pregnant woman. No adequate and well-controlled studies have been conducted in pregnant women with either topical or parenteral forms. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when this drug was applied to mucous membrane areas. Multiple birth defects have been reported in the fetus of a patient treated with the IV formulation.

Comments:
-This drug can cause fetal harm when administered to a pregnant woman.
-Cases of ventricular septal defect, miscarriage, cleft lip, and cleft palate have been reported with topical administration of this drug.
-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 reproduction studies have not been conducted with the topical formulation of this drug; however, when given IV at equivalent human doses, this drug was embryotoxic and teratogenic. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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 decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Fluorouracil topical Breastfeeding Warnings

Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. It might be possible to breastfeed safely during intermittent therapy with an appropriate period of breastfeeding abstinence, but the duration of abstinence is not clear.

Use is contraindicated.

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

Comments:
-If this drug is used during breastfeeding, complete blood count and differential should be monitored in the infant.

See references

References for pregnancy information

  1. "Product Information. Efudex (fluorouracil topical)." Valeant Pharmaceuticals, Costa Mesa, CA.
  2. "Product Information. Tolak (fluorouracil topical)." Hill Dermaceuticals Inc, Sanford, FL.
  3. "Product Information. Fluorouracil Topical (fluorouracil topical)." A-S Medication Solutions, Chicago, IL.
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. "Product Information. Fluoroplex (fluorouracil topical)." Aqua Pharmaceuticals LLC, Malvern, PA.

References for breastfeeding information

  1. "Product Information. Efudex (fluorouracil topical)." Valeant Pharmaceuticals, Costa Mesa, CA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Fluoroplex (fluorouracil topical)." Aqua Pharmaceuticals LLC, Malvern, PA.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  6. "Product Information. Tolak (fluorouracil topical)." Hill Dermaceuticals Inc, Sanford, FL.
  7. "Product Information. Fluorouracil Topical (fluorouracil topical)." A-S Medication Solutions, Chicago, IL.

Further information

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