Stelazine and Pregnancy

In small studies and clinical experience involving Stelazine and pregnancy, the medication did not appear to pose a significant risk to the child. However, because the full risks are not known, the FDA has classified Stelazine as a pregnancy Category C medication. If you are taking Stelazine and pregnancy occurs, your healthcare provider will consider the benefits and risks in your particular situation.

Is Stelazine Safe During Pregnancy?

Stelazine® (trifluoperazine hydrochloride) may not be safe for women who are pregnant. This is based on a few small studies and clinical experience that involved using Stelazine in pregnant women.

Stelazine and Pregnancy Category C

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 studied in pregnant humans but that 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.
There have not been any large, adequate studies done on the use of Stelazine during pregnancy in humans. No animal studies have been performed, either. Small studies and clinical experience suggest that the drug may be a reasonable choice for pregnant women with schizophrenia. Although it crosses the placenta to the fetus, it appears that the drug probably does not pose significant risk to the mother or child. However, the full risks of using Stelazine during pregnancy are not known.
A pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the mother outweigh any possible risks to the unborn child.
Pregnancy and Pain

Stelazine Drug Information

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