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In animal studies involving Xeloda and pregnancy, the drug was shown to increase the risk of miscarriages and birth defects. As a result, the FDA has classified the drug as a pregnancy Category D medication. If you are taking Xeloda and pregnancy occurs, your healthcare provider will weigh the benefits and risks before making a recommendation. He or she may still prescribe Xeloda if the benefits to the pregnant woman outweigh the risks to the unborn child.
Xeloda and Pregnancy: An OverviewXeloda® (capecitabine) is generally not considered safe for women who are pregnant. In animal studies that looked at the effects of Xeloda during pregnancy, the drug caused miscarriages and birth defects.
Xeloda and Pregnancy Category DThe 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 D is given to medicines that have shown clear evidence of risk to the fetus in studies. Pregnancy Category D is a stronger warning than a pregnancy Category C classification. However, a pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
Xeloda was given a pregnancy Category D rating because of problems in animal studies. When given to pregnant mice, Xeloda increased the risk of miscarriages and birth defects, including a cleft palate and eye problems.