Colitis Home > Uceris and Pregnancy
Is it safe for women to take Uceris (budesonide ER) during pregnancy? Animal studies have shown that this drug may cause miscarriages, low birth weights, and bone defects. However, no studies have been done in pregnant women, so it is unknown whether this drug would cause similar problems in humans.
Uceris™ (budesonide ER) is a prescription medicine used for ulcerative colitis treatment. Animal studies have suggested that Uceris, like other steroids, may not be safe for use during pregnancy.
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. Uceris is classified as a pregnancy Category C medicine.
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 budesonide (the drug's active ingredient) was given to pregnant rats and rabbits, it increased the risk of miscarriages, low birth weights, and bone defects. Uceris 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 a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
If you are pregnant or thinking of becoming pregnant while taking Uceris, let your healthcare provider know. He or she will consider both the benefits and risks before making a recommendation in your particular situation.