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Folic acid Pregnancy and Breastfeeding Warnings

Brand names: FA-8, FaLessa, Folacin-800, Folvite

Medically reviewed by Drugs.com. Last updated on Aug 17, 2023.

Folic acid Pregnancy Warnings

Use is considered acceptable.

AU TGA pregnancy category: A
US FDA pregnancy category: A

Comments:
-Folic acid deficiency is common during pregnancy.
-Folic acid deficiency during pregnancy may lead to fetal malformations such as neural tube defects.
-This medication is used to treat megaloblastic anemia during pregnancy.
-The US Center for Disease Control (CDC) recommends all women of childbearing age consume 0.4 mg folic acid daily, from diet and/or supplementation.
-The recommended dose for women who previously birthed a child with neural tube defect is 4 mg/day starting 1 month before conception and continuing until the 12th week of gestation.
-Women on antiepileptic medications may need supplementation.

Very high folic acid doses have caused fetal abnormalities in lab animals. Harmful effects on human fetuses have not been reported. Folic acid deficiency during pregnancy has been linked to neural tube defects, placental abruption, gestational hypertension, abortion, placenta previa, premature delivery, low birth weight, and megaloblastic anemia. There are no controlled data in human pregnancy.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

US FDA pregnancy category A: Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

See references

Folic acid Breastfeeding Warnings

Use is considered acceptable.

Excreted into human milk: Yes

Comments:
-Folic acid is actively secreted in breast milk.
-Folate accumulation in milk takes precedent over maternal needs.
-Folic acid levels in colostrum are low, but rise with continued lactation.
-Supplementation may not be needed if nutritional habits are good; poor nutritional habits may lead to maternal deficiency and megaloblastic anemia.
-The National Academy of Sciences recommends 0.28 mg per day of folic acid for lactating women; supplementation is recommended if dietary intake is inadequate.
-The American Academy of Pediatrics considers folic acid compatible with breast feeding.
-No adverse effects have been seen in breastfed infants of women receiving folic acid.

See references

References for pregnancy information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Cerner Multum, Inc. Australian Product Information.
  3. Briggs GG, Freeman RK. Drugs in Pregnancy and Lactation. Philadelphia, PA: Wolters Kluwer Health. 2015.
  4. Product Information. Folic Acid (folic acid). Method Pharmaceuticals, LLC. 2017.

References for breastfeeding information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Cerner Multum, Inc. Australian Product Information.
  3. Briggs GG, Freeman RK. Drugs in Pregnancy and Lactation. Philadelphia, PA: Wolters Kluwer Health. 2015.
  4. Product Information. Folic Acid (folic acid). Method Pharmaceuticals, LLC. 2017.

Further information

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