Cholecalciferol Pregnancy and Breastfeeding Warnings
Brand names: BProtected Pedia D-Vite, Bio-D-Mulsion, Bio-D-Mulsion Forte, Carlson D, Celebrate Vitamin D3 Quick-Melt, D 1000 IU, D-Vita Drops, D2000, D3, D3-5, D3-50, D400, Ddrops, Decara, Delta D3, Enfamil D-Vi-Sol, Maximum D3, Replesta, Replesta Children's, Replesta NX, Thera-D 2000, Thera-D 4000, Thera-D Rapid Repletion, UpSpringbaby D, Vitamin D3
Medically reviewed by Drugs.com. Last updated on Jan 17, 2024.
Cholecalciferol Pregnancy Warnings
Use is not recommended unless there is a deficiency.
AU TGA pregnancy category: Exempt
US FDA pregnancy category: Not assigned
Comments:
-Vitamin D supplementation should begin a few months prior to pregnancy.
Animal studies at high doses have shown teratogenicity. There are no controlled data in human pregnancy. Because vitamin D raises calcium levels, it is suspect in the pathogenesis of supravalvular aortic stenosis syndrome, which is often associated with idiopathic hypercalcemia of infancy, but excessive vitamin D intake or retention has not been found consistently in these mothers. A study of 15 patients with maternal hypoparathyroidism, treated with high dose vitamin D during pregnancy (average 107,000 international units per day) to maintain normal calcium levels, produced all normal children. Vitamin D deficiency is associated with reduced fetal growth, neonatal hypocalcemia (with and without convulsions), rickets, and defective tooth enamel.
AU TGA pregnancy category Exempt: Medicines 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 decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.
Cholecalciferol Breastfeeding Warnings
The required dose of vitamin D during lactation has not been adequately studied; doses similar to those for pregnant women have been suggested.
Chronic ingestion of large doses of vitamin D by the mother may lead to hypercalcemia in the breastfed infant.
Use is not recommended unless the clinical condition of the woman requires treatment.
Excreted into human milk: Yes
Comments:
-Make allowance for any maternal dose if prescribing this product to a breast fed infant.
-Consider monitoring the infant's serum calcium if the mother is receiving pharmacologic doses of vitamin D.
-Vitamin D supplementation is recommended in exclusively breast fed infants.
See also
References for pregnancy information
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee. Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm 2010.
- Briggs GG, Freeman RK. Drugs in Pregnancy and Lactation. Philadelphia, PA: Wolters Kluwer Health. 2015.
References for breastfeeding information
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- Briggs GG, Freeman RK. Drugs in Pregnancy and Lactation. Philadelphia, PA: Wolters Kluwer Health. 2015.
- IOM (Institute of Medicine). Dietary Reference Intakes for Calcium and Vitamin D. Washington, DC: The National Academies Press. 2011.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
