Dehydroepiandrosterone Pregnancy and Breastfeeding Warnings

Brand names: DHEA, Intrarosa

Medically reviewed by Drugs.com. Last updated on Jul 10, 2023.

Dehydroepiandrosterone Pregnancy Warnings

Animal studies have not been conducted with prasterone (vaginal insert), including embryofetal development or fertility studies. 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.

Prasterone (vaginal insert) is not indicated for use in pregnancy or in women of childbearing potential.
-According to some authorities: Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk summary: No data available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Prasterone (vaginal insert) is only indicated for use in postmenopausal women.
-According to some authorities:
---The potential for adverse effects of this drug on embryofetal development are thought to be related to the formation of estradiol and testosterone upon metabolism of this drug; however, the potential risk in humans is unknown.
---If pregnancy occurs during use of this drug, immediately discontinue therapy.
---This drug can weaken condoms, diaphragms or cervical caps made of latex.

See references

Dehydroepiandrosterone Breastfeeding Warnings

Prasterone (vaginal insert) is not indicated for use in breastfeeding women.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There is no information on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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