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The FDA has classified Adalat CC as a pregnancy Category C medication, meaning it may not be safe to take the drug during pregnancy. During animal studies of Adalat CC and pregnancy, the drug increased the risk of miscarriages and birth defects (such as problems with the fingers or toes, rib deformities, and cleft palate). However, a healthcare provider may still prescribe Adalat CC to a pregnant woman if the benefits to the woman outweigh the risks to her unborn child.
An Overview of Adalat and PregnancyFor people who are pregnant, Adalat CC® (nifedipine) may not be safe. This is based on animal studies that looked at the effects of Adalat CC during pregnancy.
Adalat 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.
Adalat CC was given a pregnancy Category C rating because of potential problems in animal studies. When given to pregnant rabbits, mice, and rats, Adalat 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.
Adalat CC is sometimes used to stop preterm labor, especially when other medications have failed. Adalat CC helps to relax the smooth muscle of the uterus, stopping premature labor. Because Adalat CC is not approved for stopping preterm labor, this is considered an "off-label" use.