Use is contraindicated.

AU TGA pregnancy category: X
US FDA pregnancy category: Not assigned.

Risk summary: This drug may endanger pregnancy by producing uterine contractions, bleeding, and expulsion of the products of conception.

Comments:
-Patients of childbearing potential should be apprised of the potential harm to the fetus.
-Pregnancy should be excluded prior to initiation.
-Use of adequate methods of contraception should be encouraged.
-If the patient becomes pregnant while taking this drug, treatment should be discontinued.
-When used for medical termination of pregnancy, contraception should be resumed immediately after the termination of pregnancy is confirmed.

Animal studies have revealed evidence of embryotoxicity when this drug was administered during organogenesis; animal models have revealed skeletal abnormalities and cleft palate at maternally toxic doses. There are no controlled data in human pregnancy. There are reports of uterine contractions, abortions, skull defects, cranial nerve palsies, facial malformations, and limb defects when this drug was used during the first trimester. Abortion, miscarriages (including incomplete miscarriage), Moebius syndrome, amniotic band syndrome, premature birth, fetal death, and uterine rupture have occurred later in gestation.

Male animal models have revealed a potential dose-associated risks of pre- and post-implantation losses and a decrease in the number of live pups born at the highest dose.

AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of 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

This drug is a prostaglandin E1 analog, which normally appears in colostrum and milk. When 12 lactating patients were given 600 mcg oral doses during the first 4 days postpartum, the average Tmax was 1 hour after administration at a Cmax of 20.9 ng/L.

Use is not recommended.
-Some experts recommend: Caution is recommended.

Excreted into human milk: Yes

Comment: Some experts state that use may cause diarrhea in the breastfed infant.

See references