Sanctura XR and Pregnancy

The FDA has classified Sanctura XR (trospium XR) as a pregnancy Category C medication, meaning that the medication may not be safe for use during pregnancy. When the active ingredient of Sanctura XR was given to pregnant animals, there appeared to be birth defects. However, be sure to talk to your healthcare provider if you are taking Sanctura XR and pregnancy occurs; he or she may still prescribe Sanctura XR if the benefits outweigh the risks.

 

Is Sanctura XR Safe During Pregnancy?

Sanctura® XR (trospium XR) is a prescription medication used for treating an overactive bladder. Sanctura XR may not be safe for use in pregnant women, although the full risks are not known at this time. When given to pregnant animals, Sanctura XR may cause problems.
 

Sanctura XR and 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 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.
 
When trospium chloride (the active ingredient in Sanctura XR) was given to pregnant rats, a few of the newborn rats had birth defects (although it is not clear if the risk of birth defects was increased). No studies have evaluated the effects of this medication in pregnant women.
 
It is important to note that animals do not always respond to medicines in the same way that humans do. A pregnancy Category C medicine may still be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
 
(Sanctura XR 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;