Xopenex HFA and Pregnancy
In studies on Xopenex HFA and pregnancy, the medication did not cause any problems when it was given to pregnant animals. However, in animal studies where albuterol (a drug very similar to Xopenex HFA) was given to pregnant mice and rabbits, the newborns had birth defects and brain and skull problems. Xopenex HFA is a pregnancy Category C medication, meaning that a healthcare provider may still prescribe it to a woman who is pregnant. If you are using Xopenex HFA and pregnancy occurs, talk to your healthcare provider immediately.
Xopenex HFA® (levalbuterol HFA) may not be safe for women who are pregnant. It is similar to another medication called albuterol. Xopenex HFA contains the active form of the albuterol molecule, while albuterol products contain both the inactive and active forms of the molecule. Although animal studies of Xopenex HFA did not show any problems during pregnancy, animal studies that looked at the effects of albuterol during pregnancy showed an increased risk of birth defects.
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.
Xopenex HFA was given a pregnancy Category C rating because of potential problems in animal studies of albuterol. Even though animal studies of Xopenex HFA did not show any problems, Xopenex HFA is very similar to albuterol (which did show problems in animal studies). When given to mice, albuterol caused birth defects, especially cleft palate. In rabbits, albuterol caused brain and skull problems. In humans, albuterol can increase the heart rate and blood sugar levels in the fetus.
However, it is important to note that animals do not always respond to medicines 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 pregnant woman outweigh any possible risks to the unborn child. Because "rescue" medications like Xopenex HFA are usually essential for people with asthma, healthcare providers typically recommend that pregnant women continue to take Xopenex HFA.