Mycophenolate and Pregnancy

Using mycophenolate during pregnancy could cause miscarriage, cleft palate, or various other problems. Due to these and other serious risks, the medication has a pregnancy Category D rating. This means that it should not be used in pregnancy unless the benefits to the mother clearly outweigh the risks to the fetus.

Can Pregnant Women Use Mycophenolate?

Mycophenolate (CellCept®, Myfortic®) is a prescription medication used to prevent organ rejection in people who have had a heart, kidney, or liver transplant. It belongs to a class of drugs known as immunosuppressants (medicines that reduce the activity of the immune system). Mycophenolate may cause harm to an unborn baby if used during pregnancy.

What Is Pregnancy Category D?

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. Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents.
A pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
Mycophenolate appears to increase the risk for miscarriage when used during the first trimester (the first three months of pregnancy). It also increases the risk for a variety of birth defects, including defects of the:
  • External ear
  • Face (such as cleft lip and palate)
  • Hands and feet
  • Heart
  • Esophagus
  • Kidneys.
Because of these risks, mycophenolate is not recommended for use during pregnancy. However, there could be cases when the medicine is used despite the risks. For example, if other anti-rejection medicines are not an option, the risks of transplant rejection in a pregnant woman may outweigh the risks to the fetus from using the medicine.
If you are a woman of childbearing potential, your healthcare provider will make sure you are not pregnant by giving you a pregnancy test within one week of starting mycophenolate. Your healthcare provider will also talk to you about using at least two effective forms of birth control. These two forms of birth control should be used starting at least four weeks before mycophenolate treatment begins until six weeks after stopping treatment.
You should also know that mycophenolate may make birth control pills less effective (see Drug Interactions With Mycophenolate for more information).
Pregnancy and Pain

Mycophenolate Drug Information

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