Pitocin Pregnancy Warnings
AU TGA pregnancy category: A
US FDA pregnancy category: Not assigned
Risk Summary: Based on wide clinical experience and this drug's chemical structure and pharmacological properties, a risk of fetal abnormalities is not expected when used as indicated.
Comments:
-This drug is indicated for the medical induction of labor; available data and information are inadequate to define the benefits to risks considerations for elective induction use.
No standard embryofetal development studies have been done with this drug; one study in rats administered oxytocin early in pregnancy at doses approximately 3000 times that used in humans resulted in embryonic fetal loss. This drug has contributed significantly to the safety of childbirth, however, there have been instances of idiosyncratic sensitivity of the uterus resulting in fetal anoxia. There are no known indications for oxytocin use in the first trimester of pregnancy other than in relation to spontaneous or induced abortion. There are no controlled data in human pregnancy.
AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
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Pitocin Breastfeeding Warnings
Caution is recommended
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments: This drug is not expected to cause harmful effects in the newborn.
Oxytocin is an essential lactation hormone, although studies with exogenous oxytocin to improve lactation success or treat breast engorgement have not shown benefit. There are studies with maternal oxytocin use during labor that suggests it may reduce sucking behavior in the newborn, however these studies lack consistency. Oxytocin is not expected to cause harmful effects in the newborn because it passes into the alimentary tract where it undergoes rapid inactivation.
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