Pertzye and Pregnancy
Research has not been done to determine the possible risks of using Pertzye in pregnant women or animals. At this time, it is unclear if the drug would cause harm to a fetus. Although it is a pregnancy Category C medication, there may be times when the benefits for the mother outweigh the potential risks to the unborn child.
Pertzye® (pancrelipase) is a prescription medication used to treat exocrine pancreatic insufficiency, such as the type of deficiency that occurs with cystic fibrosis. 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. Pertzye is classified as a pregnancy Category C medication.
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.
Pertzye was given a pregnancy Category C rating because it has not been formally studied in any pregnant humans or animals. The potential risks the drug might present, 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, things that are associated with problems for the fetus during pregnancy. In many and perhaps most cases, the benefits will likely outweigh the risks.
If you are pregnant or thinking about becoming pregnant, let your healthcare provider know before taking Pertzye. He or she will consider both the benefits and risks before making a recommendation in your particular situation.