Use is not recommended during the second and third trimester of pregnancy.

US FDA pregnancy category: Not assigned

Risk summary:
Insufficient data available on the use of this drug in pregnant women to inform a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Comment:
-When diabetes is not well-controlled during pregnancy, it poses a higher risk to the mother for conditions like diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. Additionally, it increases the likelihood of major birth defects, stillbirth, and morbidity related to macrosomia in the fetus.

Administration of this drug to rats at exposures 11 times the 20 mg clinical dose during a period of renal development corresponding to the late second and third trimester of human pregnancy resulted in adverse renal pelvic and tubule dilatations that did not reverse completely. In a prenatal and postnatal development study in rats, maternal mortality was observed at and above 40 mg/kg (79 times the clinical dose of 20 mg based on AUC) and fetal toxicity was observed at 200 mg/kg (361 times the clinical dose of 20 mg based on AUC) dose. Evidence of embryofetal toxicity was reported in rabbits at a dose of 150 mg/kg/day (368 times the clinical dose of 20 mg based on AUC). There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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The presence of this drug was reported in rat milk. Based on a study in rats, a risk to the developing kidney in juvenile rats was found during the period of renal development, which corresponds to the late second and third trimester of human renal development.

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Data not available
Excreted into animal milk: Yes

Comments:
-No data available regarding the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production.
-Based on animal data, this drug is believed to be excreted in human milk.
-There is a renal development risk associated with the use of this drug in a breast-fed child.

See references