Cystic Fibrosis Home > Zenpep and Pregnancy

As a pregnancy Category C medicine, Zenpep (pancrelipase) should only be given to a pregnant woman when the benefits to the mother outweigh the potential risks. This drug has not been formally studied in any pregnant humans or animals, so the risks of taking it during pregnancy are largely unknown. Therefore, talk to your healthcare provider before taking this product during pregnancy.

Can Pregnant Women Take Zenpep?

Zenpep® (pancrelipase) is a prescription medication used to treat pancreatic digestive enzyme deficiencies, 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.

What Is Pregnancy Category C?

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. Zenpep 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.
Zenpep was given a pregnancy Category C rating because it has not been formally studied in any pregnant humans or animals. The potential risks, which are largely unknown at this time, 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.

Final Thoughts

If you are pregnant or thinking of becoming pregnant while taking Zenpep, let your healthcare provider know. He or she will consider both the benefits and risks before making a recommendation in your particular situation.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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