DuoNeb and Pregnancy

Studies involving DuoNeb and pregnancy showed that one of the components (albuterol) caused birth defects in pregnant mice and rabbits. As a result, the FDA has classified DuoNeb as a pregnancy Category C medication. However, if you are taking DuoNeb and pregnancy occurs, your healthcare provider may still prescribe it if he or she believes that the benefits to you outweigh any risks to the fetus.

Is DuoNeb Safe During Pregnancy?

DuoNeb® (ipratropium and albuterol solution) is a prescription medication used to treat chronic obstructive pulmonary disease (COPD). DuoNeb may not be safe for use in pregnant women. Albuterol (one of the active ingredients in the medication) has been shown to increase the risk of birth defects in pregnant animals.

DuoNeb 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.
The two components of DuoNeb have different pregnancy category ratings. Albuterol is a pregnancy Category C medication, while ipratropium is a pregnancy Category B medication. Therefore, the combination product DuoNeb carries a pregnancy Category C rating (which is less safe, compared to a pregnancy Category B rating).
Albuterol was given a pregnancy Category C rating because of potential problems in animal studies. When given to mice, it caused birth defects, especially a cleft palate. In rabbits, albuterol caused brain and skull problems. In humans, it can increase the heart rate and blood sugar levels in the fetus. Ipratropium (the other component) appears to be safer to use during pregnancy and has not been shown to cause any problems in animal studies.
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 woman outweigh any possible risks to the unborn child.
Pregnancy and Pain

DuoNeb Inhalation Solution

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