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Pregnancy: There are no adequate and well-controlled studies with dapagliflozin in pregnant women. Animal data in rats have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters of human pregnancy. Therefore, the use of dapagliflozin is not recommended during the second and third trimesters of pregnancy. When pregnancy is detected, treatment with dapagliflozin should be discontinued.
Lactation: It is not known whether the dapagliflozin is excreted in human milk; the drug is excreted into milk in rats. The risk to the newborns/infants cannot be excluded. Therefore, dapagliflozin is not recommended in breastfeeding women.
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