Cardene and Pregnancy

In animal studies involving Cardene and pregnancy, the medication caused an increased risk of miscarriages, low birth weights, low survival rates, and difficult labor when given to pregnant animals. Therefore, the FDA has classified Cardene as a pregnancy Category C medication, meaning it may not be safe for use during pregnancy. However, a healthcare provider may prescribe Cardene to a pregnant woman if the benefits outweigh the possible risks to her unborn child.

 

An Overview of Cardene and Pregnancy

For people who are pregnant, Cardene® (nicardipine hydrochloride) may not be safe. This is based on animal studies that looked at the effects of Cardene during pregnancy.
 

Cardene 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.
 
Cardene was given a pregnancy Category C rating because of potential problems in animal studies. When given to pregnant rabbits, Cardene increased the risk of miscarriage. When given to pregnant rats, Cardene caused difficult labor, low birth weights, low survival rates, and decreased weight gain in the newborn rats.
 
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 pregnant women if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
 
(Cardene and Pregnancy Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;