Empagliflozin Pregnancy and Breastfeeding Warnings

Brand names: Jardiance

Medically reviewed by Drugs.com. Last updated on Aug 28, 2023.

Empagliflozin Pregnancy Warnings

Use should be avoided, especially during the second and third trimesters of pregnancy.

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

Risk Summary: There is limited data in pregnant women to determine a drug-associated risk for major birth defects and miscarriage. Based on animal data, this drug may cause adverse renal effects in the developing fetus.

Comments:
-Poorly controlled diabetes in pregnancy increases the risk of adverse maternal and fetal outcomes.

Animal studies have revealed evidence of adverse renal changes and embryofetal toxicity. Administration of this drug to pregnant animals during the period of organogenesis at doses up to 154 times the maximum clinical dose based on AUC resulted in maternal/fetal toxicity, malformations, and reduced offspring body weights. In juvenile rats, direct exposure to this drug at doses approximately 13 times the maximum clinical dose caused increased kidney weights and renal tubular/pelvic dilatations. These findings occurred during a period of renal development in rats corresponding to the late second and third trimester of human renal development. Animal studies do not indicate direct or indirect harmful effects with respect to fertility. There are no controlled data in human pregnancy.

Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications. Fetal risks of poorly controlled diabetes in pregnancy include an increased risk for major birth defects, stillbirth, and macrosomia-related morbidity.

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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Empagliflozin Breastfeeding Warnings

Use is not recommended

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-A risk to the breastfed infant cannot be excluded; there is a potential for serious adverse effects on postnatal renal development.
-An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Drug accumulation was observed in the milk of lactating animals. Studies in juvenile rats with direct exposure demonstrated pelvic and tubular dilations of the kidney during maturation. Human kidney maturation occurs in utero and during the first 2 years of life; thus, a potential for serious harm to the developing kidney may exist for infants exposed to this drug during breastfeeding. However, some experts anticipate low amounts of this drug in human breastmilk due to high levels of plasma protein binding.

See references

Further information

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