Brovana and Pregnancy

In animal studies on Brovana (arformoterol tartrate) and pregnancy, high doses of Brovana increased the risk of birth defects, death, and various other problems when it was given to pregnant rats and rabbits. Due to these potential risks, healthcare providers will prescribe Brovana to pregnant women only if the benefits outweigh the risks. If you are taking Brovana and pregnancy occurs, notify your healthcare provider.

Is Brovana Safe During Pregnancy?

Brovana® (arformoterol tartrate) may not be safe for women who are pregnant, although the full risks are not known at this time. Although Brovana has never been studied in pregnant women, potential problems were found during animal studies.

Brovana 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 appear to cause harm to the fetus in animal studies but that have not yet been adequately studied in pregnant women. Also, medicines that have not been studied in any pregnant women or animals are automatically given a default pregnancy Category C rating.
Brovana was given a pregnancy Category C rating because of potential problems in animal studies. When given to pregnant rats and rabbits, extremely high doses of Brovana increased the risk of birth defects, pup death at birth or during lactation, and various other 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. It is important to note that Brovana is approved only to treat chronic obstructive pulmonary disease (COPD), a disease which is very uncommon in women of reproductive age.
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