Farxiga (Dapagliflozin) Use During Pregnancy
Farxiga (dapagliflozin) should not be used during pregnancy, particularly in the second and third trimesters, due to adverse renal effects observed in animal studies and lack of adequate human safety data. 1
FDA Drug Label Guidance
The FDA label for dapagliflozin explicitly states that DAPAGLIFLOZIN TABLETS are not recommended during the second and third trimesters of pregnancy based on animal data showing adverse renal effects. 1
Key Safety Concerns:
Renal developmental toxicity: Animal studies demonstrated adverse renal pelvic and tubule dilatations that were not fully reversible when dapagliflozin was administered during periods corresponding to the late second and third trimesters of human pregnancy, at exposures as low as 15-times the 10 mg clinical dose. 1
Limited human data: There is insufficient data in pregnant women to determine drug-associated risk for major birth defects or miscarriage. 1
Juvenile animal studies: Direct dosing to juvenile rats showed increased kidney weights and renal pelvic/tubular dilatations at all dose levels tested, with effects that did not fully reverse within a one-month recovery period. 1
Clinical Management Algorithm
If Patient is Currently Taking Farxiga:
Discontinue immediately upon pregnancy confirmation, especially if beyond first trimester 1
Switch to insulin therapy for diabetes management, as insulin does not cross the placenta and is the standard of care for diabetes in pregnancy 2
Avoid other SGLT2 inhibitors as they share the same mechanism of action and likely similar risks 1
For Diabetes Management in Pregnancy:
Insulin is the treatment of choice for both type 1 and type 2 diabetes during pregnancy, as poorly controlled diabetes increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and increases fetal risk for major birth defects, stillbirth, and macrosomia. 1
Metformin may be considered in certain circumstances, though insulin remains preferred 2
Oral antidiabetic drugs are generally not recommended due to known effects on the fetus including congenital abnormalities, fetal hyperinsulinemia, macrosomia, and neonatal hypoglycemia. 3
Important Caveats
Accidental Exposure:
If a patient becomes pregnant while taking dapagliflozin, discontinue the medication immediately but this does not necessitate termination of pregnancy 1
Counsel the patient about the theoretical risks based on animal data while acknowledging the limited human data 1
Arrange close monitoring with maternal-fetal medicine specialists 1
Background Risks:
The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with HbA1c >7% and can be as high as 20-25% with HbA1c >10%. 1
Poorly controlled diabetes itself poses significant risks to both mother and fetus, making appropriate glycemic control essential regardless of the medication used. 1
Breastfeeding Considerations:
- The FDA label does not provide specific guidance on breastfeeding, and there is no available data on dapagliflozin excretion in human milk or effects on the breastfed infant. 1
The priority must be maintaining maternal glycemic control while avoiding medications with known or potential fetal risks—insulin remains the gold standard for diabetes management throughout pregnancy. 2, 1