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Pregnancy: There are insufficient human data regarding the use of Febuxostat in pregnant women to determine the risk of adverse fetal outcomes. In animal studies, there was no evidence of teratogenicity when rats and rabbits were given oral Febuxostat, however, there was an increase in neonatal mortality and reduction in neonatal body weight gain when pregnant rats were given oral Febuxostat. Following oral administration, Febuxostat crossed the placenta in pregnant rats and was detected in fetal tissues. Febuxostat should not be used during pregnancy.
Lactation: There are no data regarding the presence of Febuxostat in human milk, and the effects, if any, on a breastfeeding infant or milk production are unknown. Febuxostat is excreted in rat milk up to approximately 7 times that of the plasma concentration. Febuxostat should not be used while breastfeeding.
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