Schizophrenia Home > Fanapt and Pregnancy

In animal studies of pregnancy and Fanapt (iloperidone), the medication appeared to cause several problems, such as an increased risk of miscarriages and stillbirths, low fetal weight, and skeletal abnormalities. However, animals do not always respond to medicines the same way that humans do. Therefore, a healthcare provider may recommend that a pregnant woman take this drug if the benefits outweigh the risks.

Is Taking Fanapt While Pregnant Safe?

Fanapt® (iloperidone) is a prescription schizophrenia medication. Based on the results of animal studies, Fanapt may not be safe for use in pregnant women.
 

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.
 
When given to rats during pregnancy and while breastfeeding, high doses of Fanapt caused the following problems:
 
  • Prolonged pregnancy, labor, and delivery
  • Increased miscarriages and stillbirths
  • Decreased fetal and newborn weight
  • Skeletal abnormalities
  • Decreased offspring survival.
     
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, 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.
 
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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