Pregnancy Based on animal data showing adverse renal effects drug is not recommended during second and third trimesters of pregnancy Limited data in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy In animal studies, adverse renal pelvic and tubule dilatations, that were not fully reversible, were observed in rats when administered during a period of renal development corresponding to late second and third trimesters of human pregnancy, at all doses tested Clinical considerations Poorly controlled diabetes in pregnancy increases...