Dulera and Pregnancy
Based on the results of animal studies, Dulera (mometasone/formoterol) is considered a pregnancy Category C medicine. This means that it may not be safe for use by women who are expecting. When high doses of the active ingredients in Dulera were given to pregnant animals, it caused miscarriages, birth defects, and several other problems.
I'm Pregnant -- Can I Take Dulera?Dulera® (mometasone/formoterol) is a prescription medication used to treat asthma. It is classified as a pregnancy Category C medication, which means that it may not be safe for use during pregnancy.
What Is Pregnancy Category C?The U.S. Food and Drug Administration (FDA) uses a pregnancy 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 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.
Dulera has not been studied in pregnant women. However, the active ingredients in Dulera, mometasone and formoterol, have caused problems in animal studies. When high doses of mometasone were given to pregnant mice, rats, and rabbits, it increased the risk of miscarriages, birth defects, and other problems. Some of the other problems included:
- Cleft palate
- Head malformations
- Low birth weights
- Difficult labor
- Decreased fetal survival.
When given to pregnant rats at extremely high doses, formoterol, the other active ingredient in Dulera, decreased fetal weight and caused miscarriages and stillbirths. At lower doses, it delayed bone formation.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.