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Korlym and Pregnancy

Women who are pregnant or may become pregnant should not take Korlym (mifepristone), as this drug can harm a developing fetus. If taken during pregnancy, this medication will cause the lining of the uterus to break down, ending the pregnancy. Women must have a negative pregnancy test before starting Korlym treatment, and must use an effective, nonhormonal birth control method.

Can Pregnant Women Take Korlym?

Korlym™ (mifepristone) is a prescription medicine used in certain people with Cushing's syndrome. This medicine must not be used in women who are pregnant or may become pregnant, as it will cause the pregnancy to end.

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. Korlym is classified as a pregnancy Category X medication.
Pregnancy Category X is given to medicines that show problems to the fetus in animal studies or in human use of the drug. With this category, the potential risks clearly outweigh the possible benefits.
In animal studies, Korlym increased the risk for miscarriages when given in low doses to pregnant mice, rats, and rabbits. The drug also increased the risk for skull deformities in the offspring of the pregnant rabbits. It did not appear to cause birth defects in pregnant mice, rats, or monkeys.
More importantly, Korlym blocks the action of progesterone, a hormone in the body that is necessary for pregnancy to continue. By blocking progesterone, Korlym causes the lining of the uterus to break down, ending the pregnancy. A different medication (Mifeprex®), which contains the same active ingredient as Korlym, is used to terminate early pregnancies (to cause abortions).
If you are a woman of childbearing potential, your healthcare provider will make sure you are not pregnant before prescribing Korlym. You will also need to have a negative pregnancy test before restarting the medicine if you stop taking it for more than 14 days.
It is very important that women who can become pregnant use an adequate form of birth control throughout treatment, and for at least one month after treatment ends, to prevent a pregnancy from occurring. Korlym can decrease the effectiveness of hormonal birth control (see Korlym Drug Interactions). Therefore, nonhormonal contraception must be used. Talk to your healthcare provider about the best nonhormonal birth control for your particular situation.
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