In animal studies involving phenothiazines (such as Prolixin) and pregnancy, the medicine increased the risk of miscarriages and birth defects. However, animals do not always respond to medicines in the same way that humans do. Therefore, if a woman is taking Prolixin and pregnancy occurs, her healthcare provider may have her continue the medication if its benefits outweigh the possible risks.
Is Prolixin Safe During Pregnancy?
Prolixin® (fluphenazine) may not be safe for women who are pregnant. This is based largely on other similar medications, as little is known about the use of Prolixin during pregnancy.
Prolixin 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.
When given to pregnant animals, phenothiazines (such as Prolixin) can increase the risk of miscarriages and birth defects. 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 her outweigh any possible risks to the unborn child.
Recommendations for Prolixin and Pregnancy
If you are taking Prolixin and pregnancy occurs (or if you are thinking of becoming pregnant while taking the drug), let your healthcare provider know. He or she will consider both the benefits and risks of taking Prolixin during pregnancy before making a recommendation for your particular situation.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
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