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The FDA has classified Nifediac CC as a pregnancy Category C medication due to the potential risks the drug may have on the fetus. When Nifediac CC was given to pregnant animals, it increased the risk of miscarriages and birth defects. Therefore, if you are taking Nifediac CC and pregnancy occurs (or if you are thinking of becoming pregnant), be sure to talk to your healthcare provider about the risks and benefits of taking the medication.
An Overview of Nifediac and PregnancyFor people who are pregnant, Nifediac CC® (nifedipine) may not be safe. This is based on animal studies that looked at the effects of Nifediac CC during pregnancy.
Nifediac and Pregnancy Category CThe U.S. Food and Drug Administration (FDA) uses a pregnancy 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 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.
Nifediac CC was given a pregnancy Category C rating because of potential problems in animal studies. When given to pregnant rabbits, mice, and rats, Nifediac CC increased the risk of miscarriages and birth defects. These birth defects included problems with fingers or toes, rib deformities, and cleft palate.
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 pregnant woman outweigh any possible risks to the unborn child.
Nifediac CC is sometimes used to stop preterm labor, especially when other medications have failed. The drug helps to relax the smooth muscle of the uterus, stopping premature labor. Since Nifediac CC is not approved for treating preterm labor, this is considered an "off-label" use.