Proventil and Pregnancy

The FDA has classified Proventil as a pregnancy Category C medication, meaning that the drug may not be safe for women who are pregnant. Studies involving Proventil and pregnancy showed that the drug had adverse effects in mice and rabbits. However, "rescue" medications such as Proventil are usually essential for people with asthma, and healthcare providers often recommend that women continue to take Proventil during pregnancy.

 

Is Proventil Safe to Take During Pregnancy?

Proventil® (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.
 

Proventil and Pregnancy Category C

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 was given a pregnancy Category C rating because of potential problems in animal studies. When given to mice, Proventil caused birth defects, especially cleft palate. In rabbits, Proventil caused brain and skull problems. In humans, Proventil can increase the heart rate and high blood sugar 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 are usually essential for people with asthma, healthcare providers typically recommend that pregnant women continue to take Proventil. Several references state that Proventil is compatible with pregnancy. In fact, albuterol, the active ingredient of Proventil, is sometimes used to treat premature labor, usually without causing any problems in the fetus.
 
(Proventil and Pregnancy Continued: Page 2)
Add this article to your Favorites     Email this article     Print
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;