Not recommended

AU TGA pregnancy category: D
US FDA pregnancy category: Not Assigned

Risk Summary: Limited data with this combination drug and its individual components in pregnant women is insufficient to determine a drug-associated risk for major birth defects or miscarriage; based on animal data showing adverse renal effects, dapagliflozin is not recommended during the second and third trimesters of pregnancy.

Comments:
-If pregnancy is detected, this drug should be discontinued.
-Poorly controlled diabetes is a risk to both the mother and fetus therefore, alternative therapy will be necessary to control blood sugars.

Animal studies with saxagliptin have shown reproductive toxicity at high doses; rat studies with dapagliflozin have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters of human pregnancy. Poorly controlled diabetes during pregnancy increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery and delivery complications and the fetal risk for major birth defects, still birth, and macrosomia related morbidity. The estimated background risk of major birth defects in women with pregestational diabetes and a HbA1c greater than 7 is 6% to 10%; with a HbA1c greater than 10, this risk has been reported to be as high as 20% to 25%. There are no adequate and well controlled studies in pregnant women.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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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Not recommended

Excreted into human milk: Dapagliflozin (unknown); Saxagliptin (unknown)
Excreted into animal milk: Dapagliflozin (yes); Saxagliptin (yes)

Comments:
-Because of the potential for serious adverse reactions in breastfed infant, women should be advised not to take this drug while breastfeeding.

Juvenile rats exposed to dapagliflozin showed a risk of renal pelvic and tubular dilations during maturation. Since kidney maturation occurs during the first 2 years of life, there may be a risk to the developing kidney of the breastfed infant.

See references