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Mifeprex and Pregnancy

A pregnant woman should only take Mifeprex (mifepristone) if she has decided to terminate the pregnancy. Mifeprex is a pregnancy Category X medication. If a woman continues with her pregnancy after unsuccessful treatment with Mifeprex, there is a risk for birth defects or other dangerous complications.

Can Pregnant Women Take Mifeprex?

Mifeprex® (mifepristone) is a prescription medicine approved to end an early pregnancy (seven weeks or less). Because this medicine causes an abortion, it should only be used by pregnant women who wish to terminate their pregnancy.
 

What Is Pregnancy Category X?

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 taken during pregnancy. Mifeprex is classified as a pregnancy Category X drug.
 
Pregnancy Category X is given to medicines that show problems to the fetus in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the potential benefits.
 
In animal studies, Mifeprex increased the risk for miscarriage when given in low doses to pregnant mice, rats, and rabbits. The drug also caused birth defects, including defects of the skull, in the offspring of the pregnant rabbits. However, it did not appear to increase the risk for birth defects in pregnant mice, rats, or monkeys.
 
More importantly, the medication blocks the action of progesterone, a hormone in the body that is necessary for pregnancy to continue. By blocking progesterone, Mifeprex causes the lining of the uterus to break down, ending the pregnancy.
 
It is also important to note that Mifeprex is often given in combination with misoprostol (Cytotec®) when used to induce an abortion. Misoprostol is a prostaglandin, a hormone-type substance found naturally in the body. This drug causes the uterus to contract, leading to pregnancy termination. Misoprostol has been associated with birth defects when given to pregnant women in the first trimester, including defects of the skull, face, and extremities (arms and legs).
 
If Mifeprex and misoprostol do not successfully end your pregnancy, your healthcare provider will talk to you about other options, including a surgical abortion. You should know that there is a possibility of birth defects if you choose to continue the pregnancy.
 
However, there are cases of women continuing their pregnancy after taking Mifeprex and giving birth to newborns with no detectable birth defects. Until more information is known, however, it is not possible to say how high the risk of birth defects is with Mifeprex use.
 
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