Dapagliflozin and Breastfeeding
Dapagliflozin is not recommended during breastfeeding and should be avoided; women should discontinue breastfeeding if dapagliflozin treatment is necessary.
FDA Drug Label Guidance
The FDA label for dapagliflozin explicitly addresses breastfeeding safety 1:
- There is no information regarding the presence of dapagliflozin in human milk, the effects on the breastfed infant, or the effects on milk production 1
- Advise women that use of dapagliflozin is not recommended while breastfeeding 1
- The concern stems from potential risk to the developing human kidney, as human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur 1
Animal Data Raising Concerns
Animal studies demonstrate concerning findings that inform the breastfeeding recommendation 1:
- Dapagliflozin was present in rat milk at a milk/plasma ratio of 0.49, indicating transfer into milk at approximately 50% of maternal plasma concentration 1
- Juvenile rats directly exposed to dapagliflozin showed risk to the developing kidney, specifically renal pelvic and tubular dilatations during maturation 1
- These renal effects occurred during periods corresponding to human kidney development that extends through the first 2 years of life 1
Clinical Decision Framework
When a breastfeeding mother with type 2 diabetes requires treatment 1:
- Discontinue breastfeeding if dapagliflozin is deemed necessary for maternal health
- Alternative diabetes medications with established safety profiles during breastfeeding should be prioritized (such as metformin or insulin, which have extensive lactation safety data)
- The decision must weigh the benefits of breastfeeding against the potential serious adverse reactions in the breastfed infant, particularly kidney-related complications 1
Key Pitfalls to Avoid
- Do not assume safety based on lack of reported adverse events - the absence of human data is itself a reason for caution, not reassurance 1
- Do not rely on the "probably safe" assumption that applies to some medications - dapagliflozin has specific mechanistic concerns related to kidney development that distinguish it from drugs with merely insufficient data 1
- The critical window of vulnerability extends through the first 2 years of life, meaning even older breastfed infants remain at potential risk 1