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Zelnorm During Pregnancy

Taking Zelnorm during pregnancy is generally considered safe. This is because the medication did not appear to cause any side effects to fetuses in previous animal studies. It is important to note, however, that animals do not always respond to medicines the same way that humans do. A healthcare provider may prescribe Zelnorm to a pregnant woman if he or she believes that its benefits outweigh the possible risks to her unborn child.

 

Is Zelnorm Safe During Pregnancy? -- An Overview

For people who are pregnant, Zelnorm® (tegaserod maleate) is generally considered safe. This is based on animal studies that looked at the effects of Zelnorm during pregnancy.
 
In March 2007, Zelnorm was taken off the market in the United States because it was shown to increase the risk for a heart attack, angina, or stroke. In July 2007, the United States Food and Drug Administration (FDA) announced that Zelnorm will be available to people who meet certain criteria through a special program called a "treatment IND" (see Zelnorm Recall for more information). However, as of April 2, 2008, Zelnorm is no longer available under the treatment IND program, although it may still be available in certain emergency situations.
 

Zelnorm and Pregnancy Category B

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 B is given to medicines that have not been studied in pregnant humans but do not appear to cause harm to the fetus in animal studies.
 
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category B medicine may be given to a pregnant woman if her healthcare provider believes that its benefits to her outweigh any possible risks to the unborn child.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;