Is Foradil Safe During Pregnancy?
Foradil® (
formoterol fumarate) may not be safe for women who are pregnant. In animal studies that looked at the effects of the drug during pregnancy, it caused miscarriages and stillbirths.
Foradil and 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. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that 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.
Foradil was given a pregnancy Category C rating because of the potential problems it caused in animal studies. When given to pregnant rats at extremely high doses, the drug caused miscarriages and stillbirths. At lower doses, it caused decreased fetal weights and delayed bone formation.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. A pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the mother outweigh any possible risks to the unborn child. Because medications like Foradil can be essential for people with
asthma, healthcare providers often recommend that women continue to take Foradil during pregnancy.
