Fluorouracil (systemic) (monograph) 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 equivalent 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.
Use is contraindicated.
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.
-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.
-Based on animal data, fertility in both males and females may be impaired while receiving this drug.
-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.
-Men treated with this drug should be advised not to father a child during and for up to 6 months after.
-Advice men on conservation of sperm because of the possibility of irreversible infertility due to therapy.
-Genetic counseling is recommended if pregnancy occurs while taking this drug.
See references
Fluorouracil (systemic) (monograph) 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.
Use is contraindicated.
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
