Prostin E2 and Pregnancy

Prostin E2 (dinoprostone vaginal suppository) is approved for use in pregnant women. It is given to terminate a pregnancy and to help remove the contents of the uterus after an abortion. However, if a woman continues with the pregnancy after using Prostin E2, there is a risk for birth defects or other dangerous complications.

Can Pregnant Women Receive Prostin E2?

Prostin E2® (dinoprostone vaginal suppository) is a prescription medication that causes uterine contractions. It is used in certain women to empty the contents of the uterus. Based on the results of animal studies, this drug may cause fetal harm. However, this is not normally a concern, because Prostin E2 is used in situations in which the fetus has already died (a "missed miscarriage") or an elective abortion is desired.

What Is Pregnancy Category C?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is used during pregnancy. Prostin E2 is classified as a pregnancy Category C drug.
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies. In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Prostin E2 is a synthetic version of prostaglandin E2, a hormone that is naturally found in the body. Prostaglandin E2 is important for labor and delivery to occur. It causes the cervix to thin and soften so the unborn baby can pass through during delivery. It also causes uterine contractions.
When given to pregnant rats and rabbits, prostaglandin E2 increased the risk for skeletal birth defects. Based on these studies, it is possible that continuing a pregnancy after using Prostin E2 could increase the risk for birth defects. However, studies have not shown that Prostin E2 causes birth defects. It should be noted that the medication causes uterine contractions that can be harmful to the fetus, which is intended for an elective abortion; it is of no concern if the fetus has already died.
Because of the potential for fetal harm, the manufacturer of Prostin E2 recommends that if the drug does not lead to a complete abortion, other procedures should be used to complete the process. An incomplete abortion could also harm a woman by causing infection and dangerous bleeding. Therefore, your healthcare provider will carefully monitor you during Prostin E2 use to ensure the desired effect is achieved.

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Last reviewed by: Kristi Monson, PharmD
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