Actos Use In Pregnancy & Lactation

Use in Pregnancy: Pregnancy Category C.
Pioglitazone was not teratogenic in rats at oral doses up to 80 mg/kg or in rabbits given up to 160 mg/kg during organogenesis (approximately 17 and 40 times the maximum recommended human oral dose based on mg/m², respectively). Delayed parturition and embryotoxicity (as evidenced by increased post-implantation losses, delayed development and reduced fetal weights) were observed in rats at oral doses of 40 mg/kg/day and above (approximately 10 times the maximum recommended human oral dose based on mg/m²). No functional or behavioral toxicity was observed in offspring of rats. In rabbits, embryotoxicity was observed at an oral dose of 160 mg/kg (approximately 40 times the maximum recommended human oral dose based on mg/m²). Delayed postnatal development, attributed to decreased body weight, was observed in offspring of rats at oral doses of 10 mg/kg and above during late gestation and lactation periods (approximately 2 times the maximum recommended human oral dose based on mg/m²).
There are no adequate and well-controlled studies in pregnant women. Actos should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Because current information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital anomalies, as well as increased neonatal morbidity and mortality, most experts recommended that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible.
No adequate human data have been generated to demonstrate the safety of pioglitazone, alone or in combination with metformin or glimepiride during pregnancy.
Use in Lactation: Pioglitazone is secreted in the milk of lactating rats. It is not known whether Actos is secreted in human milk. Because many drugs are excreted in human milk, Actos should not be administered to a breast-feeding woman or breast feeding should be discontinued if the use of the drug is considered essential.