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Niacin Pregnancy and Breastfeeding Warnings

Niacin is also known as: B-3-50, B3-500-Gr, HDL Benefit, Niacin SR, Niacor, Niacor B3, Niaspan, Nico-400, Nicobid Tempules, Nicolar, Nicotinex, Nicotinic Acid, Slo-Niacin

Niacin Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk. AU TGA pregnancy category: Exempt US FDA pregnancy category: C

Animal reproduction studies have not been conducted with this drug. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans. 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Niacin Breastfeeding Warnings

In one study of lactating women who were taking 2 to 60 mg of niacin per day, the average milk concentration ranged from 1.17 to 2.75 mcg/mL, and was directly proportional to dietary intake. The recommended daily allowance (RDA) for niacinamide during lactation is 18 to 20 mg. Dietary supplementation is only necessary in cases of poor nutritional intake.

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: Yes Comments: -Lipid altering doses of this drug have the potential for serious adverse reactions in nursing infants.

See references

References for pregnancy information

  1. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  2. Australian Government, Department of Health and Ageing, National Health and Medical Research Council "Nutrient Reference Values for Australia and New Zealand Including Recommended Dietary Intakes Available from: URL: https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/n35.pdf." ([2006]):
  3. "Product Information. Niacor (niacin)." Upsher-Smith Laboratories Inc, Minneapolis, MN.
  4. "Product Information. Niacin (niacin)." 21st Century Healthcare Inc, Tempe, AZ.

References for breastfeeding information

  1. "Product Information. Niacin (niacin)." 21st Century Healthcare Inc, Tempe, AZ.
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  3. Australian Government, Department of Health and Ageing, National Health and Medical Research Council "Nutrient Reference Values for Australia and New Zealand Including Recommended Dietary Intakes Available from: URL: https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/n35.pdf." ([2006]):
  4. "Product Information. Niacor (niacin)." Upsher-Smith Laboratories Inc, Minneapolis, MN.

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