Zavesca

THE SAFETY OF MIGLUSTAT (ZAVESCA) DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION CAN CAUSE HARM TO YOUR BABY

What is miglustat?

Miglustat is an enzyme inhibitor that prevents formation of fatty chemicals that cause symptoms of type I Gaucher disease. Type I Gaucher disease is a genetic condition that prevents an important enzyme (that breaks down these fatty chemicals) from being made. Enzyme replacement therapy can supplement the lack of enzyme produced by the body in some patients.

What is miglustat used to treat?

Miglustat is a prescription medication used to treat the genetic condition known as type I Gaucher disease, specifically in patients who cannot take enzyme replacement therapy.

How does miglustat work?

Miglustat inhibits an enzyme that produces a fatty chemical in the body; the build-up of this fatty chemical throughout the body causes type I Gaucher disease symptoms. Type I Gaucher disease is characterized by an enlarged liver or spleen, low red blood cell and platelet counts, chronic fatigue, and lung or bone disease.

If I am taking miglustat, can it harm my baby?

Studies in humans are limited. Animal studies showed decreased weight and a reduced chance of survival of the baby. Miglustat is expected to cross the placenta to reach the baby. The use of miglustat during pregnancy is contraindicated. Women with uncontrolled type I Gaucher disease who become pregnant have an increased risk of spontaneous abortion as well as harm to themselves and the developing baby.

If I am taking miglustat and become pregnant, what should I do?

It is important to speak with your doctor immediately if you are taking miglustat and become pregnant. There is limited safety information in pregnant women; therefore, miglustat is contraindicated in pregnancy.

If I am taking miglustat, can I safely breastfeed my baby?

Information in humans is lacking, but miglustat is expected to be excreted in the breast milk. It is generally recommended to either discontinue bmiglustat or discontinue breastfeeding if remaining on miglustat.

If I am taking miglustat, will it be more difficult to get pregnant?

Information on fertility effects in humans is lacking. In animal studies, there was a decrease in male sperm development; however, a study in 7 humans males found no effect of miglustat on sperm development.

If I am taking miglustat, what should I know?

It is important to speak with your doctor to determine if you should continue miglustat therapy during pregnancy. Human studies are lacking. Miglustat is commonly contraindicated in pregnancy because of a lack of safety information in pregnant women. Uncontrolled type I Gaucher disease is also associated with serious side effects in both mother and baby.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of Zavesca during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert report about gaucher disease here and reports about the individual medications used to treat this and other conditions here.   Additional information can also be found in the resources below. 

For more information about miglustat during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:

Read the whole report
General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.