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Pregnancy: Risk Summary: There are no data with GAMASTAN use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with GAMASTAN. It is not known whether GAMASTAN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. In the U.S. general population, the estimated backgrounds risk of major birth defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Lactation: Risk Summary: There is no information regarding the presence of GAMASTAN in human milk, the effect on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for GAMASTAN and any potential adverse effects on the breastfed infant from GAMASTAN or from the underlying maternal condition.
