Dapagliflozin / metformin Pregnancy and Breastfeeding Warnings

Brand names: Xigduo XR

Medically reviewed by Drugs.com. Last updated on May 6, 2022.

Dapagliflozin / metformin Pregnancy Warnings

Use is not recommended, especially during the second and third trimesters of pregnancy.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary:
-Limited data is available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-If pregnancy is detected, this drug should be discontinued.
-Therapy with metformin may result in ovulation in some anovulatory premenopausal women.
-Poorly controlled diabetes during pregnancy increases maternal and fetal risks for adverse outcomes.

In animal studies, dapagliflozin exposure during periods of animal development, which correspond to the late second and third trimesters of human development, showed increased kidney weights and renal pelvic and tubular dilation. There are no adequate and well-controlled studies on pregnant women.

Clinical considerations:
Poorly controlled diabetes increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth, and macrosomia related morbidity. Insulin is recommended as the drug of choice during pregnancy.

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.

See references

Dapagliflozin / metformin Breastfeeding Warnings

In juvenile rats exposed to dapagliflozin during maturation, renal pelvic and tubular dilatations were observed, posing a risk to the developing kidney. The long-term functional consequences of these effects are unknown. Data from well-conducted studies indicate that metformin levels in milk are low and infants would receive less than 0.5% of their mother's weight-adjusted dosage. One sizeable prospective study found no adverse effects in breastfed infants. Metformin should be used with caution while nursing newborn and premature infants and those with renal impairment. Dapagliflozin should be avoided during the first two years of life. As functional maturation of the human kidneys continues in the first 2 years of life, dapagliflozin-associated dilated renal pelvis and tubules could constitute a potential risk for human renal maturation.

Use is not recommended when breastfeeding.
-According to some authorities: Use is contraindicated.

Excreted into human milk: Unknown (dapagliflozin); Yes (metformin)
Excreted into animal milk: Yes (dapagliflozin); Yes (metformin)

Comments:
-The effects in the nursing infant or on milk production are unknown; the risk to newborns or infants cannot be excluded.
-This drug may cause serious adverse reactions in breastfed infants.

See references

Further information

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