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In animal studies on Symbyax and pregnancy, the medication increased the risk of newborn death, low birth weight, and delayed bone formation. As a result, the FDA has classified it as a pregnancy Category C medicine. If a woman is taking Symbyax and pregnancy occurs, her healthcare provider will weigh the benefits to the mother against the risks to the unborn child.
Is Symbyax Safe During Pregnancy? -- An OverviewSymbyax® (olanzapine and fluoxetine) may not be safe for women who are pregnant. In animal studies that looked at the effects of the drug on pregnancy, Symbyax caused problems in the newborn animals.
Symbyax and Pregnancy Category CThe 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 rats and rabbits, Symbyax increased the risk of low birth weight, delayed bone formation, and newborn death. 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 mother outweigh any possible risks to the unborn child.
One of the two active ingredients in Symbyax is fluoxetine, a selective serotonin reuptake inhibitor (SSRI). SSRIs, when given during the third trimester, may cause serious complications in the newborn that require breathing or feeding support and a longer hospital stay. Talk with your healthcare provider about the risks and benefits of decreasing or discontinuing your dose of fluoxetine during the third trimester of pregnancy.