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Zinc acetate Pregnancy and Breastfeeding Warnings

Zinc acetate is also known as: Galzin

Zinc acetate Pregnancy Warnings

Zinc acetate has been assigned to pregnancy category A by the FDA. Animal studies have failed to reveal evidence of teratogenicity and fetal harm. Human pregnancy studies have failed to reveal fetal abnormalities in all trimesters of pregnancy. However, the manufacturer states the studies in human pregnancy cannot rule out all possibilities of fetal harm. Therefore, the manufacturer states zinc acetate is recommended for use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.

Zinc is a common component of prenatal vitamin supplements and has been used safely for the treatment of Wilson's disease in pregnant patients. The recommended daily allowance of zinc during pregnancy is 15 mg per day. The effect of excessive dosages of zinc acetate in pregnancy are not known. It is suggested that the normally recommended dosage of zinc acetate for Wilson's disease should not be exceeded during pregnancy. Successful pregnancies in Wilson's disease are rare if the patient is left untreated. Many women of child-bearing age experience amenorrhea, impaired fertility, stillbirth and repeat spontaneous abortions. Decoppering treatment usually results in a return to normal reproductive activity. Alternative agents used in the treatment of Wilson's disease, such as penicillamine and trientine, have been reported to lead to teratogenic effects in animal models, but this has not been validated in humans.

See references

Zinc acetate Breastfeeding Warnings

The recommended daily allowance of elemental zinc during lactation is 19 mg during the first 6 months and 16 mg during the second 6 months. Zinc is needed for the normal growth and development of breast-fed infants. However, the effect on the breast-fed infant of higher dosages used in Wilson's disease is not known.

There are no data on the excretion of zinc acetate into human milk. Elemental zinc is known to be excreted into human milk and may lead to copper deficiency in the nursing infant. The manufacturer recommends that women on zinc therapy not nurse their infants.

See references

References for pregnancy information

  1. Goldenberg RL, Tamura T, Neggers Y, et al. "The effect of zinc supplementation on pregnancy outcome." JAMA 274 (1995): 463-8
  2. Brewer GJ "Practical recommendations and new therapies for Wilson's disease." Drugs 50 (1995): 240-9
  3. Yarze JC, Martin P, Munoz SJ, Friedman LS "Wilson's disease: current status." Am J Med 92 (1992): 643-54
  4. "Product Information. Galzin (zinc acetate)." Gate Pharmaceuticals, Sellersville, PA.
  5. Mahan LK, Escott-Stump S. "Krause's Food, Nutrition, and Diet Therapy. 9th ed." Philadelphia, PA: W.B. Saunders Company (1996):

References for breastfeeding information

  1. "Product Information. Galzin (zinc acetate)." Gate Pharmaceuticals, Sellersville, PA.

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