Serevent and Pregnancy

Is Serevent Safe During Pregnancy?

Serevent^® (salmeterol xinafoate) may not be safe for women who are pregnant. In animal studies involving Serevent and pregnancy, the drug caused birth defects.

 

Serevent 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.

 

Serevent was given a pregnancy Category C rating because of potential problems in animal studies. When given to rabbits, Serevent caused birth defects, including cleft palate and skull problems.

 

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 medications like Serevent can be essential for people with asthma, healthcare providers often recommend that women continue to take Serevent during pregnancy.