Perforomist and Pregnancy

The FDA has classified Perforomist (formoterol solution) as a pregnancy Category C medication, meaning that the medication may not be safe to take during pregnancy. In animal studies involving Perforomist and pregnancy, the medication increased the risk of miscarriages, stillbirths, low fetal weights, and delayed bone formation. However, a healthcare provider may still prescribe Perforomist to a pregnant woman if the benefits outweigh the risks.

 

Is Perforomist Safe to Take During Pregnancy?

Perforomist™ (formoterol solution) may not be safe for women who are pregnant. Although Perforomist has never been studied in pregnant women, potential problems were found during animal studies.
 

Perforomist 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.
 
Perforomist was given a pregnancy Category C rating because of potential problems in animal studies. When given to rats, Perforomist increased the risk of miscarriages, stillbirths, low fetal weights, and delayed bone formation.
 
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 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 Perforomist is only approved to treat chronic obstructive pulmonary disease (COPD), a disease that is very uncommon in women of reproductive age.
 
(Perforomist 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;