Linzess and Pregnancy
As a pregnancy Category C medication, Linzess (linaclotide) may not be safe for use in women who are expecting. Animal studies have shown that this drug may reduce the size of the uterus, decrease fetal weight, and even cause death. You should not take this medicine while pregnant unless your healthcare provider determines that the benefits outweigh the risks.
Can I Take Linzess When Pregnant?
Linzess™ (linaclotide) is a prescription medication used to treat irritable bowel syndrome with constipation and chronic idiopathic constipation. Based on the results of animal studies, it may not be safe for pregnant women to take Linzess, although the full risks are currently unknown.
What Is 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. Linzess is classified as a pregnancy Category C medication.
Pregnancy Category C is given to medicines that have not been studied in pregnant humans but appear to cause harm to the fetus in animal studies. Medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Linzess has not been studied in pregnant women. It has been studied in pregnant mice, rats, and rabbits. In these studies, the drug did not cause birth defects or other problems when given to pregnant rats and rabbits, even in extremely high doses. In pregnant mice, very high doses reduced the size of the uterus (the womb) and reduced the weight of the unborn mice. These high doses also caused death in some of the pregnant mice.
However, 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 her unborn child.