Contraindicated

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

Risk Summary: This drug is contraindicated during pregnancy because there is no need for pregnancy prevention; epidemiologic studies and meta-analysis have shown no increased risk of genital or non-genital birth defects following maternal exposure prior to conception or during early pregnancy.

Comments:
-Discontinue use if pregnancy is confirmed.

Animal studies have failed to reveal evidence of adverse developmental effects. Epidemiological data have failed to reveal an increased risk of birth defects following maternal exposure to low dose combined hormonal contraceptives prior to conception or during early pregnancy. In a small number of women, intrauterine concentrations of contraceptive steroids were shown to be similar to levels observed in combination oral contraceptive use. Pregnancy outcomes with use of this drug have not been specifically reported. 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 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

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-Many experts advise women to use non-estrogen containing contraception until their child is completely weaned.
-There is no evidence that the presence of contraceptive steroids in breastmilk adversely affect the breastfed infant's health.

It is important to weigh the increased risk of VTE during the postpartum period when considering contraceptive choices; most experts consider progestin-only contraception acceptable for nursing mothers at any time postpartum. The clotting risk of combination contraceptive products (including this product) preclude its use before 3 weeks postpartum. Experts in the US believe the advantages of combined hormonal contraceptives generally outweigh the theoretical or proven risks between 3 weeks and 6 months postpartum; however, evidence is poor for its effect on lactation, especially for preterm or ill infants. Estrogens may reduce the quantity and change the composition of breast milk. Guidance from the World Health Association advises against combined oral contraceptives in nursing mothers before 42 days postpartum and further suggests the disadvantages of using combined oral contraceptives generally outweigh the advantages between 6 weeks and 6 months postpartum. After 6 months postpartum, combination contraceptives, including oral tablets, the transdermal patch and vaginal ring, can be used, but progestin-only methods are preferred if breastfeeding is to be continued.

See references