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Fluorouracil Pregnancy and Breastfeeding Warnings

Fluorouracil is also known as: Adrucil

Medically reviewed on October 6, 2017

Fluorouracil Pregnancy Warnings

Animal studies revealed evidence of embryolethality and teratogenicity (i.e., abortion, resorptions, delays in growth, cleft palate, skeletal defects, deformed appendages [paws and tails], micro-anophthalmos) at doses lower than the human dose of 12 mg/kg. 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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

AU, UK: Contraindicated
US: This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: D
US FDA pregnancy category: D

Comments:
-Based on its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.
-Women of childbearing potential should be advised to avoid becoming pregnant and to use an effective method of contraception during therapy with this drug and for up to 6 months after discontinuing therapy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential hazard to the fetus and genetic counseling is recommended.
-Men treated with this drug should be advised not to father a child during and for up to 6 months after discontinuing therapy. Advice men on conservation of sperm because of the possibility of irreversible infertility due to therapy.

See references

Fluorouracil Breastfeeding Warnings

Most experts consider breastfeeding 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.

UK: Contraindicated
AU, US: A decision should be made to discontinue breastfeeding or 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.
-If this drug is used during breastfeeding, a complete blood count and differential is recommended in the infant.

See references

References for pregnancy information

  1. "Product Information. Fluorouracil (fluorouracil)." BluePoint Laboratories, Norwich, NY.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. 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 -]):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Fluorouracil (fluorouracil)." BluePoint Laboratories, Norwich, NY.

Further information

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

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