Xopenex and Pregnancy
Although animal studies on Xopenex and pregnancy did not show problems for the fetus, animal studies on albuterol (a similar drug) showed an increase in birth defects. Because Xopenex contains the active form of albuterol, it may not be safe for pregnant women. However, "rescue" medications like Xopenex are usually essential for asthma treatment, so if you are taking Xopenex and pregnancy occurs, your healthcare provider will weigh the benefits and risks in your situation.
Xopenex® (levalbuterol hydrochloride) may not be safe for women who are pregnant. The drug is similar to another medication, albuterol. While albuterol products contain both the inactive and active forms of the molecule, Xopenex only contains the active form of the albuterol molecule. Although animal studies on Xopenex 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 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.
Xopenex was given a pregnancy Category C rating because of the potential problems that resulted during animal studies of albuterol. Even though animal studies of Xopenex did not show any problems, the drug is similar to albuterol. When given to pregnant mice, albuterol caused birth defects, especially cleft palate. In pregnant rabbits, albuterol caused brain and skull problems in the baby rabbits. 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 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 "rescue" medications like Xopenex are usually essential for people with asthma, healthcare providers typically recommend that pregnant women continue to take Xopenex.