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Estradiol topical Pregnancy and Breastfeeding Warnings

Estradiol topical is also known as: Estrace Vaginal Cream, Estring, Vagifem

Estradiol topical Pregnancy Warnings

Animal studies have revealed that high doses of estrogens have produced urogenital malformations in the offspring. There are no adequate and well-controlled studies in pregnant women. AU TGA pregnancy category B 3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use is contraindicated during pregnancy. AU TGA pregnancy category: B 3 US FDA pregnancy category: X Comments: -If pregnancy occurs while this drug is being, treatment should be discontinued immediately. -There is little or no increased risk of birth defects in children born to women who have used estrogens and progestins inadvertently during early pregnancy.

Estradiol topical Breastfeeding Warnings

Use is not recommended. Excreted into human milk: Yes Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.

Estrogen use in nursing women has been shown to affect the quantity and quality of the breast milk.

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