Pancreaze and Pregnancy
As a pregnancy Category C medicine, Pancreaze (pancrelipase) should only be given to a pregnant woman if the benefits to the mother outweigh the potential risks to her unborn child. This drug has not been studied in pregnant women, so it is largely unknown how it may affect an unborn child. Make sure to discuss the risks with your healthcare provider.
Pancreaze® (pancrelipase) is a prescription medication used to treat pancreatic digestive enzyme deficiencies (such as the type of deficiency that occurs with cystic fibrosis), known medically as exocrine pancreatic insufficiency (EPI). At this time, it is unclear if Pancreaze 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. Pancreaze 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.
Pancreaze 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 risks.
If you are pregnant or thinking of becoming pregnant while taking Pancreaze, let your healthcare provider know. He or she will consider both the benefits and risks before making a recommendation in your particular situation.