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 Overview
Symbyax® (
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 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 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.
Final Thoughts on Symbyax and Pregnancy
If you are taking Symbyax 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 the benefits and risks of taking the drug while pregnant before making a recommendation in your particular situation.
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