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Dapagliflozin / metformin Pregnancy and Breastfeeding Warnings

Dapagliflozin / metformin is also known as: Xigduo XR

Medically reviewed by Drugs.com. Last updated on Nov 28, 2018.

Dapagliflozin / metformin Pregnancy Warnings

Not recommended during the second and third trimesters of pregnancy

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

Risk Summary: Limited data are not sufficient to inform a drug-associated risk for major birth defects or miscarriage; animal data have shown adverse renal effects with dapagliflozin exposure during the renal development period which corresponds to the late second and third trimesters of human pregnancy

Comments:
-When 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 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 in pregnant women.

Clinical considerations: Poorly controlled diabetes increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, still birth, and macrosomia related morbidity. Insulin is generally 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

A risk to the developing kidney was observed in juvenile rats exposed to dapagliflozin during maturation, specifically renal pelvic and tubular dilatations. The long-term functional consequences of these effects are unknown. As functional maturation of the human kidneys continues in the first 2 years of life, dapagliflozin-associated dilated renal pelvis and tubules could constitute potential risk for human renal maturation.

Not recommended

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

Comments:
-Therapy with this drug is not recommended for women who are breastfeeding because of the potential for serious adverse reactions in breastfed infants.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Xigduo XR (dapagliflozin-metFORMIN)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

References for breastfeeding information

  1. "Product Information. Xigduo XR (dapagliflozin-metFORMIN)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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