Ultresa and Pregnancy
Research has not been done to determine the possible risks of using Ultresa in pregnant women or animals. At this time, it is unclear if the drug is safe during pregnancy. Although it is a pregnancy Category C medication, there may be times when the benefits of taking it during pregnancy outweigh the potential risks to the unborn child.
Ultresa® (pancrelipase) is a prescription medication used to treat pancreatic digestive enzyme deficiencies (such as the type of deficiency that occurs with cystic fibrosis), also known as exocrine pancreatic insufficiency. At this time, it is unclear if this drug is 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. Ultresa is classified as a pregnancy Category C medicine.
Pregnancy Category C is given to medicines that have not been studied in pregnant women 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.
Ultresa was given a pregnancy Category C rating because it has not been formally studied in any pregnant women or animals. The potential risks, which are currently largely unknown, must be weighed against the risks of not treating a pancreatic enzyme deficiency in a pregnant woman. Not treating the deficiency could lead to malnutrition and poor weight gain in the mother, problems that are associated with problems for the fetus during pregnancy. In many cases, the benefits will outweigh the likely risks.
If you are pregnant or thinking about becoming pregnant, let your healthcare provider know before taking Ultresa. He or she will consider both the benefits and risks before making a recommendation in your particular situation.