COPD Home > Daliresp and Pregnancy
Based on the results of animal studies, Daliresp (roflumilast) is considered a pregnancy Category C medicine. This means that it may not be safe for use by women who are expecting. When this drug was given to pregnant rats and mice, it increased the risk for miscarriages, stillbirth, and newborn death.
Can Pregnant Women Take Daliresp?Daliresp™ (roflumilast) is a prescription medication used in the treatment of chronic obstructive pulmonary disease (COPD). It belongs to a class of drugs called phosphodiesterase type-4 (PDE4) inhibitors. Based on the results of animal studies, the drug may not be safe for use during pregnancy.
What Is Pregnancy Category C?Daliresp is classified as a pregnancy Category C drug. 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. Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
In animal studies, Daliresp did not increase the risk for birth defects. However, it did increase the risk for miscarriages in rats, and stillbirth and newborn death in mice.