Is Combivent Safe During Pregnancy?
Combivent 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 pregnant women or animals are automatically given a pregnancy Category C rating.
Combivent was given a pregnancy Category C rating because of potential problems with albuterol in animal studies. When given to mice, albuterol 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 in Combivent) seems to be safer for 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.