Can a patient take Jardiance (empagliflozin) during pregnancy?

Can a Patient Take Jardiance (Empagliflozin) During Pregnancy?

No, Jardiance (empagliflozin) should not be used during pregnancy, particularly in the second and third trimesters, due to adverse renal effects observed in animal studies and lack of human safety data. 1

FDA Drug Label Guidance

The FDA label for Jardiance explicitly states that "based on animal data showing adverse renal effects, JARDIANCE is not recommended during the second and third trimesters of pregnancy." 1

• Limited data in pregnant women are insufficient to determine drug-associated risk for major birth defects and miscarriage 1
• Animal studies demonstrated renal pelvic and tubule dilatations in rats at doses approximately 13-times the maximum clinical dose when administered during periods corresponding to late second and third trimesters of human pregnancy 1
• Empagliflozin crosses the placenta and reaches fetal tissues 1

Diabetes Management in Pregnancy: Preferred Alternatives

Insulin is the preferred and first-line medication for treating hyperglycemia during pregnancy because it does not cross the placenta to a measurable extent. 2

Treatment Algorithm for Diabetes in Pregnancy:

1. First-line therapy: Lifestyle modification (medical nutrition therapy) 2
2. If glycemic targets not met: Add insulin 2
3. Avoid as first-line: Metformin and glyburide, as both cross the placenta 2
4. Do not use: Other oral and non-insulin injectable glucose-lowering medications (including SGLT2 inhibitors like Jardiance) due to lack of long-term safety data 2

Clinical Context and Rationale

• Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications 1
• Poorly controlled diabetes increases fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity 1
• The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with HbA1c >7% 1

Important Caveats

If a patient becomes pregnant while taking Jardiance, the medication should be discontinued and switched to insulin therapy under close medical supervision. The benefits of optimal glycemic control must be balanced against medication risks, but insulin remains the safest option with the most extensive safety data in pregnancy. 2

While one case report described successful use of empagliflozin during pregnancy in a patient with glycogen storage disease type Ib 3, this represents an exceptional circumstance in a rare metabolic disorder and does not constitute evidence supporting general use during pregnancy.