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Procardia XL and Pregnancy

In animal studies that looked at Procardia XL and pregnancy, the drug increased the risk of miscarriages and birth defects (such as problems with fingers or toes, rib deformities, and cleft palate). Because of these potential risks, Procardia XL is classified as a pregnancy Category C medicine, meaning it should only be prescribed if a healthcare provider believes that the benefits to the pregnant woman outweigh the possible risks to the unborn child.

An Overview of Procardia XL and Pregnancy

For women who are pregnant, Procardia XL® (nifedipine) may not be safe. This is based on animal studies that looked at the effects of Procardia XL during pregnancy.
 

Procardia XL and Pregnancy Category C

The 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.
 
Procardia XL was given a pregnancy Category C rating because of potential problems in animal studies. When given to pregnant rabbits, mice, and rats, Procardia XL 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.
 
Procardia XL is sometimes used to stop preterm labor, especially when other medications have failed. Procardia XL helps to relax the smooth muscle of the uterus, stopping premature labor. Since Procardia XL is not approved for stopping preterm labor, this is considered an "off-label" use.
 
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Drug Information on Procardia XL

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