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Use in Pregnancy: Pregnancy Category C. The safety of Sevelamer Carbonate has not been established in pregnant or lactating women. Sevelamer Carbonate should only be given to pregnant or lactating women if clearly needed and after careful risk/benefit analysis has been conducted for both the mother and fetus or infant.
Studies in animals have shown minimal reproductive toxicity when Sevelamer was administered to rats at high doses.
There have been no adequate well controlled studies in women undergoing labor and delivery.
Use in Lactation: There have been no studies of the excretion of Sevelamer in human milk, but since Sevelamer is not absorbed, excretion in breast milk is not expected.
