Contraindicated

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: Use is contraindicated in pregnancy or with a suspected pregnancy because there is no need for contraception; if a women becomes pregnant with an intrauterine device in place, there is an increased risk of ectopic pregnancy, miscarriage, sepsis, premature labor, and premature delivery.

Comments:
-If pregnancy occurs, remove intrauterine device (IUD) if possible; if IUD cannot be removed, follow pregnancy closely.

Animal studies have not been reported. Studies have not reported adverse effects on fetal and infant development with contraceptive doses of oral progestins in pregnant women. There have been cases of masculinization of the external genitalia of the female fetus at doses greater than those used for oral contraception. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: 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 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 decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

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Non-hormonal methods are preferred during breastfeeding; however, progestin-only contraceptives are considered the hormonal contraceptive of choice during lactation if needed. Evidence suggests that this drug does not affect the content or volume of breast milk nor the growth and development of the infant. Reports have demonstrated that approximately 0.1% of the maternal dose is transferred to the infant during breastfeeding. There have been isolated postmarketing cases of decreased milk production.

Use is considered acceptable

Excreted into human milk: Yes

Comments:
-This drug has been used without apparent harmful effects in the nursing infant.
-When used orally as a postcoital contraceptive, breastfeeding can resume 3 to 4 hours following dosing, or after each dose if the 2-dose method is used.

See references