COPD Home > Arcapta and Pregnancy

Due to the unknown risks to a developing fetus, Arcapta (indacaterol maleate) is classified as a pregnancy Category C medicine. This means that this drug might not be safe for use in women who are pregnant. A healthcare provider should only prescribe it to a pregnant woman when the benefits outweigh the risks.

Can Pregnant Women Use Arcapta?

Arcapta™ (indacaterol maleate) may not be safe for women who are pregnant, although the full risks are not known at this time. Although Arcapta has never been studied in pregnant women, no potential problems were found during animal studies.

What Is Pregnancy Category C?

Arcapta is classified as a pregnancy Category C drug. The U.S. Food and Drug Administration (FDA) uses a 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 adequately studied in pregnant humans but have caused fetal harm in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Although animal studies did not show any evidence that Arcapta causes birth defects, the drug was given a pregnancy Category C rating, presumably because other medications that are similar to Arcapta have a Category C rating.
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, including Arcapta, may be given to a pregnant woman if her healthcare provider believes that the benefits to the mother outweigh any possible risks to her unborn child. However, Arcapta is approved only to treat chronic obstructive pulmonary disease (COPD), a disease which is uncommon in women of reproductive age.
Also, medications like Arcapta can interfere with the way the uterus contracts during labor. In general, Arcapta should not be used during labor, unless the benefits clearly outweigh the risks.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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