Rat studies have shown adverse renal changes when empagliflozin was administered during a period of renal development corresponding to late second and third trimesters of human development. Renal pelvic and tubule dilations were observed at doses approximately 13-times the maximum clinical dose. Administration of both components during the period of organogenesis was not teratogenic in rats dosed up to 253 and 353 times the expected clinical exposure for empagliflozin and linagliptin, respectively. There are no adequate well-controlled studies in pregnant women with this combination drug or with its components.

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.

Not recommended during the second and third trimesters of pregnancy

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

Risk Summary: There are insufficient data in human pregnancy to determine a drug-associated risk for major birth defects or miscarriage; animal data have shown adverse renal effects with empagliflozin during the renal development period which corresponds to the late second and third trimesters of human pregnancy.

Comment: Poorly controlled diabetes during pregnancy increases maternal and fetal risks for adverse outcomes.

See references

Use is not recommended

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

Comments:
-Because there is a risk that empagliflozin exposure may effect postnatal renal development, breastfeeding is not recommended during use.

While it is unknown if this drug is excreted into human milk, there is potential for serious harm to the developing kidney if the breastfed infant is exposed. Human kidney maturation occurs during the first 2 years of life. This drug was found in rat milk and appears to accumulate (mean milk to plasma ratio ranging from 0.634 to 5; mean maximal milk to plasma ratio occurring 8 hours postdose). Juvenile rats directly exposed to this drug have shown renal pelvic and tubular dilations during maturation.

See references