Maternal use of oral progestins before conception or during early pregnancy has not been associated with an increased risk of genital or nongenital birth defects. There are no controlled data in human 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.

Use is not recommended

US FDA pregnancy category: Not assigned

Risk Summary: There is no need for contraception once pregnancy occurs; epidemiologic studies have not shown an increased risk of birth defects with inadvertent maternal use of oral progestins during early pregnancy.

Comments:
-This drug should be discontinued if pregnancy occurs.

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Use is considered acceptable

Excreted into human milk: Yes

Comments:
-No effects on breastfed newborns or infants is expected with progesterone-only contraceptives; no adverse effects on milk production or on the health, growth, or development of the infant have been demonstrated.

Non-hormonal methods are preferred during breastfeeding; however, progestin-only contraceptives are considered the hormonal contraceptive of choice during lactation if needed. Breast milk concentration following daily administration of 4 mg/day to lactating mothers is 5.6 ng/mL; providing an infant dose of approximately 840 ng/kg/day.

See references