Asmanex and Pregnancy

In previous animal studies involving Asmanex and pregnancy, the drug was shown to cause birth defects and miscarriages when given to pregnant mice, rats, and rabbits. Therefore, the FDA has classified Asmanex as a pregnancy Category C medication, meaning Asmanex may not be safe to take during pregnancy. However, because medications such as Asmanex can be essential for people with asthma, healthcare providers sometimes recommend that pregnant women continue to take Asmanex during pregnancy.

 

Is Asmanex Safe During Pregnancy?

Asmanex® (mometasone inhaler) may not be safe for women who are pregnant. In previous animal studies involving Asmanex and pregnancy, the drug caused birth defects and miscarriages.
 

Asmanex 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.
 
Asmanex was given a pregnancy Category C rating because of potential problems in animal studies. When given to pregnant mice, rats, and rabbits, Asmanex increased the risk of miscarriages and birth defects, including a cleft palate and head malformations. Asmanex also caused low birth weights and difficult labor.
 
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 her healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to her unborn child. Because medications like Asmanex can be essential for people with asthma, healthcare providers sometimes recommend that women continue to take Asmanex during pregnancy.
 
(Asmanex and Pregnancy Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;