Cardura XL and Pregnancy

In clinical trials, pregnant animals were given large doses of the active ingredient in Cardura XL (doxazosin XL). Based on the results of these studies, it is believed that Cardura XL may increase the risk of miscarriages and other problems. Your doctor may still prescribe Cardura XL, however, if the benefits outweigh the risks.

Can Pregnant Women Take Cardura XL?

Cardura® XL (doxazosin XL) is a prescription medicine approved to treat the symptoms of an enlarged prostate. Based on the results of animal studies, this medication may not be safe for use during pregnancy. However, it should be noted that Cardura XL is not approved for use in women.
 

What Is Pregnancy Category C?

The 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 C is given to medicines that have not been adequately studied in pregnant humans but did appear to cause harm to the fetus in animal studies.
 
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
When given to pregnant rats and rabbits at high doses, doxazosin (the active ingredient in Cardura XL) did not increase the risk for birth defects. Extremely high doses increased the risk for fetal death (miscarriages) in rabbits.
 
Studies in rats also showed that newborn rats that were exposed to doxazosin during pregnancy had slight developmental delays.
 
It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, pregnancy Category C medicines, including Cardura XL, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
 
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