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Niacinamide Pregnancy and Breastfeeding Warnings

Niacinamide Pregnancy Warnings

Use is considered acceptable.

AU TGA pregnancy category: Exempt
US FDA pregnancy category: Not assigned

Comments:
-This vitamin is an essential nutrient needed for tissue respirations, lipid metabolism, and glycogenesis.
-Deficiency during pregnancy is uncommon unless nutrition is poor.

Animal studies are not available. There are no controlled data in human pregnancy. A 1948 study showed an association of niacinamide deficiency to pregnancy-induce hypertension, but other B vitamins are also associated with PIH. Niacinamide is actively transported to the fetus, with higher levels in the fetus and newborn than the mother.

AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

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

Niacinamide Breastfeeding Warnings

Use is considered acceptable.

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

Comments:
-The precursor to this vitamin (niacin) is actively excreted in breast milk; transfer of this vitamin is probable.
-If dietary intake of niacin is adequate, supplementation is not needed.

See references

References for pregnancy information

  1. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ([1999]):
  2. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):

References for breastfeeding information

  1. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):

Further information

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