Flovent and Pregnancy

In previous studies involving Flovent and pregnancy, the drug caused slow embryo growth and birth defects in pregnant mice, rats, and rabbits. However, it is important to keep in mind that animals do not always respond to medicines the same way that humans do. Certain medications are often essential for people with asthma, and this is sometimes the case with Flovent. As a result, healthcare providers sometimes recommend that women continue to take Flovent during pregnancy.

 

Is Flovent Safe During Pregnancy?

Flovent® HFA (fluticasone HFA) may not be safe for women who are pregnant. In animal studies that looked at the effects of Flovent HFA during pregnancy, the drug caused birth defects.
 
This article will use the names "Flovent" and "Flovent HFA" interchangeably to refer to Flovent HFA.
 

Flovent 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.
 
Flovent HFA was given a pregnancy Category C rating because of potential problems in animal studies. When given to pregnant mice, rats, and rabbits, Flovent HFA caused slow embryo growth and birth defects (including cleft palate).
 
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 her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn child. Because medications like Flovent HFA can be essential for people with asthma, healthcare providers sometimes recommend that women continue to take Flovent HFA during pregnancy.
 
(Flovent 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;