Estradiol / norgestimate Pregnancy and Breastfeeding Warnings

Brand names: Ortho-Prefest, Prefest

Medically reviewed by Drugs.com. Last updated on Aug 28, 2023.

Estradiol / norgestimate Pregnancy Warnings

Use is contraindicated.

US FDA pregnancy category: Not assigned.

There are no controlled data in human pregnancy. There appears to be little or no increased risk of birth defects when estrogens and progestins as oral contraceptives were inadvertently used during early pregnancy.

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.

See references

Estradiol / norgestimate Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes

Comments:
-Estrogen use during lactation has been shown to decrease the quantity and quality of breast milk.
-Detectable amounts of estrogens and progestins have been found in breast milk.

See references

Further information

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