Proventil HFA and Pregnancy
In animal studies involving Proventil HFA and pregnancy, the drug was shown to have adverse effects in pregnant mice and rabbits. However, many healthcare providers believe that Proventil HFA is compatible with pregnancy. In fact, the active ingredient in Proventil HFA has been used to treat premature labor -- usually without causing any problems in the fetus.
Proventil® HFA (albuterol inhaler) may not be safe for women who are pregnant. In animal studies that looked at the effects of Proventil during pregnancy, the drug caused 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.
Proventil HFA was given a pregnancy Category C rating because of potential problems in animal studies. When given to mice, Proventil HFA caused birth defects, especially cleft palate. In rabbits, Proventil HFA caused brain and skull problems. In humans, Proventil HFA 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 Proventil HFA are usually essential for people with asthma, healthcare providers typically recommend that pregnant women continue to take Proventil HFA. Several references state that Proventil HFA is compatible with pregnancy. In fact, albuterol, the active ingredient in Proventil HFA, is sometimes used to treat premature labor, usually without causing any problems in the fetus.