Amitiza

THE SAFEY OF AMITIZA 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:

Amitiza should only be used during pregnancy if the benefits of treatment to the mom outweigh the potential risks to the baby, as determined by your doctor. There is very little data available on the use of Amitiza in pregnancy, and animal studies have shown that this medication may increase the risk of miscarriage.

What is Amitiza?

Amitiza is a medication that alleviates constipation and improves the passage of stool through the intestines. Amitiza contains the active ingredient lubiprostone. It is only available by prescription from your doctor.

What is Amitiza used to treat?

Amitiza is used to treat adults with chronic idiopathic constipation or constipation caused by chronic opioid use. It is also used to treat women 18 years of age and older who have irritable bowel syndrome with constipation (it has not been shown to work well in men). Irritable bowel syndrome is classified as abdominal discomfort with changes in bowel habits. The symptoms associated with chronic idiopathic constipation (functional constipation) and irritable bowel syndrome are similar, and may overlap in some cases. Symptoms of infrequent stools, straining during bowel movements, hard or lumpy stools, abdominal pain, bloating, and incomplete bowel movements can occur with both conditions. 

How does Amitiza work?

Amitiza changes electrolyte concentrations in your intestines to encourage the release of extra fluids. Increasing the amount of fluids in your intestines improves movement of stool through the intestines and relieves symptoms of constipation.

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

The FDA warns that Amitiza should only be used during pregnancy if the benefits of treatment to the mom outweigh the potential risks to the baby, as determined by your doctor. There is very little data available on the use of lubiprostone during pregnancy. Animal studies did not show a higher risk of birth defects with the use of lubiprostone. However, an increased risk of miscarriage/death of the offspring was observed with higher doses of lubiprostone in guinea pigs. It is suspected that this increased rate of death may have been due to changes in electrolytes and fluids within the body. The only human data that is available regarding the use of lubiprostone in pregnancy is data from a clinical trial in which six women became pregnant during clinical testing and lubiprostone was discontinued. Normal deliveries were reported in 4 of the women. One of the expecting moms had an elective abortion, and the study moderators could not get in touch with the other expecting mom. Due to the lack of data in humans and the risks observed in animal studies, many experts do not recommend the use of Amitiza during pregnancy. The manufacturer recommends that women have a negative pregnancy test prior to starting treatment with Amitiza and that effective contraception methods be used during treatment. 

Bottom line: Amitiza should only be used during pregnancy if the benefits of treatment to the mom outweigh the potential risks to the baby, as determined by your doctor. There is very little human data available on the use of lubiprostone during pregnancy, and animal studies have shown that there may be a higher risk of miscarriage with the use of this medication.

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

If you are taking Amitiza and become pregnant, you should contact your doctor immediately. Your doctor will decide if Amitiza is medically necessary or if it should be discontinued until after the birth of your baby.

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

Caution should be used if Amitiza is taken by moms who are breastfeeding. Your doctor will consider the potential risks to your baby and determine if Amitiza is medically necessary. It is unknown if lubiprostone passes into human breast milk. Lubiprostone was not shown to pass into breast milk in animal studies. If lubiprostone passes into human breast milk, this medication could cause diarrhea in the breastfed baby. No reports or studies are available that have looked at the use of lubiprostone in breastfed babies. Due to the possible risks of this medication in breastfeeding moms and the lack of available data, many experts recommend avoiding Amitiza while breastfeeding. If your doctor determines that lubiprostone is medically necessary, contact your doctor immediately if you notice that your baby has diarrhea.

Bottom line: Caution should be used if breastfeeding moms take Amitiza. It is unknown if this medication passes into breast milk, but diarrhea could develop in babies exposed to this medication. Your doctor will determine if Amitiza is medically necessary.

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

No human studies have looked at the effects of Amitiza on fertility. Animal studies have shown that lubiprostone did not affect male or female fertility or reproductive function at doses higher than the recommended dose in humans.

If I am taking Amitiza, what should I know?

Amitiza should only be used during pregnancy if the benefits of treatment to the mom outweigh the potential risks to the baby, as determined by your doctor. There is very little human data available on the use of Amitiza in pregnancy, and animal studies have shown that there may be a higher risk of miscarriage with the use of this medication.

Caution should be used if Amitiza is used while breastfeeding. It is unknown if this medication passes into breast milk. If Amitiza is present in breast milk, it could cause diarrhea in the breastfed baby.

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

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

You may find Pregistry's expert report about constipation here, and reports about various other digestive health conditions as well as the individual medications used to treat digestive disorders here.   Additional information can also be found in the resources below. 

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

U.S. Food and Drug Administration: Amitiza Prescribing Information

International Foundation for Gastrointestinal Disorders: IBS with Constipation.

About Your Gut: What Are IBS-C and CIC?

National Institute of Diabetes and Digestive and Kidney Diseases:  Definitions & Facts for Constipation

Read the whole report
Last Updated: 27-02-2019
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.