Estradiol vaginal Pregnancy Warnings
In animal studies of high dose maternal administration of synthetic estrogens, urogenital malformations were observed in the offspring. The relevance of these findings is uncertain. There are no controlled data in human pregnancy.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
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.
Use is contraindicated
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned
Risk Summary: This drug is not indicated for use during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy.
Comments:
-If pregnancy occurs, discontinue treatment immediately.
See references
Estradiol vaginal Breastfeeding Warnings
There is limited information to suggest that the route of administration and dosage form have an effect on the amount of drug transferred into breastmilk; vaginal use results in measurable amounts in the milk with unpredictable peak times, while transdermal administration with doses up to 200 mcg/day does not appear to increase estradiol or estriol in breastfed infants. Estrogens are present in human milk and can reduce milk production in lactating women; this reduction can occur at any time, but is less likely to occur once breast-feeding is well-established.
Not recommended
Excreted into human milk: Yes
Comments:
-Estrogen use during lactation has been shown to decrease the quantity and quality of breast milk.
-Some authorities contraindicate use during lactation.
See references
