Zelnorm Pregnancy Warnings
Tegaserod has been assigned to pregnancy category B by the FDA. Animal studies have revealed no evidence of fetal harm. There are no controlled data in human pregnancy. Tegaserod is only recommended for use during pregnancy when the benefit outweighs the risk.
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Zelnorm Breastfeeding Warnings
There are no data on the excretion of tegaserod into human milk. In studies with lactating rats, tegaserod and its metabolites were excreted in milk with a high milk to plasma ratio. Due to the potential for tumorigenicity reported in animal studies, the manufacturer recommends that a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
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