Colitis Home > Entocort and Pregnancy
The FDA has classified Entocort EC (budesonide EC) as a pregnancy Category C medication, meaning it may not be safe for use during pregnancy. When Entocort EC was given to pregnant rats and rabbits, it increased the risk of miscarriages, low birth weights, and bone defects. If you are taking Entocort EC and pregnancy occurs, your healthcare provider will weigh the benefits and risks before making a recommendation on taking this drug.
Entocort and Pregnancy: An OverviewEntocort® EC (budesonide EC) is a prescription medication used for treating Crohn's disease. Animal studies have suggested that Entocort EC, like other steroids, may not be safe for use during pregnancy.
Entocort and Pregnancy Category CThe U.S. Food and Drug Administration (FDA) uses a pregnancy 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 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 pregnancy Category C rating.
When Entocort EC was given to pregnant rats and rabbits, it increased the risk of miscarriages, low birth weights, and bone defects. Entocort EC has not been studied in pregnant women.
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 pregnant women if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.