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Tolvaptan Pregnancy and Breastfeeding Warnings

Tolvaptan is also known as: Samsca

Tolvaptan Pregnancy Warnings

In animal studies, cleft palate, brachymelia, microphthalmia, skeletal malformations, decreased fetal weight, delayed fetal ossification, and embryofetal death occurred. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

UK: Contraindicated US: Use during pregnancy only if the potential benefit outweighs the potential risk to the fetus. US FDA pregnancy category: C Comments: Women of childbearing potential should use adequate contraceptive measures during tolvaptan use.

Tolvaptan Breastfeeding Warnings

UK: Use is contraindicated. US: Use is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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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