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In animal studies on Gemzar and pregnancy, the medication increased the chances of miscarriages and birth defects (such as a cleft palate). Therefore, the FDA has classified Gemzar as a pregnancy Category D medicine, meaning it is generally considered unsafe for women who are pregnant. However, a healthcare provider may still prescribe Gemzar during pregnancy if he or she believes that the benefits to the pregnant woman outweigh the possible risks to the unborn child.
An Overview of Gemzar and PregnancyGemzar® (gemcitabine) is generally considered unsafe for people who are pregnant. In animal studies involving Gemzar and pregnancy, the drug increased the risk of miscarriages and birth defects.
Gemzar 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.
Gemzar was given a pregnancy Category D rating because of problems in animal studies. When given to pregnant mice, Gemzar increased the risk of miscarriages and birth defects, including cleft palate and other problems.