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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.
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.
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.
Because of the possible pregnancy risks associated with Daliresp, talk to your healthcare provider before becoming pregnant if you are taking this medication. If you are pregnant, let your healthcare provider know as soon as possible. He or she will consider both the benefits and risks before making a recommendation in your particular situation.
Written by/reviewed by: Kristi Monson, PharmD
Last reviewed by: Kristi Monson, PharmD