Irritable Bowel Syndrome Home > Amitiza and Pregnancy

It is unclear if it is safe to use Amitiza (lubiprostone) during pregnancy. Amitiza is classified as a pregnancy Category C medication, as it has been shown to increase the risk of miscarriages during animal studies. However, animals do not always respond to medicines in the same way humans do. If a woman is pregnant, Amitiza may be prescribed if the benefits outweigh the risks.

Can I Use Amitiza During Pregnancy?

Amitiza® (lubiprostone) is a prescription medication used to treat irritable bowel syndrome and chronic constipation. It is not clear if it is safe for pregnant women to take this drug.

Amitiza and Pregnancy Category C

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 C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a "default" pregnancy Category C rating.
Animal studies suggest that Amitiza probably does not increase the risk of birth defects. However, studies in pregnant guinea pigs have shown that the drug may increase the risk of miscarriages.
It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child. Amitiza has not been studied in pregnant women. During clinical studies, a few women became pregnant while taking the drug. The medication was immediately stopped, and no problems were reported.
The manufacturer recommends that women who could become pregnant should have a negative pregnancy test before starting Amitiza and should use adequate birth control in order to avoid getting pregnant while taking the drug.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
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