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Use in pregnancy: Pregnancy Category C. Oral hypoglycemic agents (including pioglitazone) are not recommended during pregnancy. Although there are no adequate and well-controlled studies of pioglitazone in pregnant women, animal studies show increased rates of post-implantation loss, delayed development, reduced fetal weights, and delayed parturition at doses 10-40 times the maximum recommended human dose. Maintaining blood glucose levels as close to normal as possible is necessary during pregnancy since abnormal blood glucose levels are associated with a higher incidence of congenital abnormalities. Insulin is recommended during pregnancy.
Use in lactation: It is not known whether pioglitazone is excreted in human milk although pioglitazone is secreted in the milk of lactating rats. Pioglitazone should not be administered to breastfeeding women.
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