Skip to Content
Is your type 2 diabetes treatment the right match?

Empagliflozin Pregnancy and Breastfeeding Warnings

Empagliflozin is also known as: Jardiance

Empagliflozin Pregnancy Warnings

Animal studies have revealed evidence that this drug crosses the placenta and reaches fetal tissues, possibly affecting renal development and maturation. In rats given approximately 13 times the maximum clinical dose during a period of renal development corresponding to late second and third trimester of human pregnancy, reversible renal pelvic and tubule dilations were observed. At maternally toxic doses, malformation of limb bones and increased embryofetal loss were observed. There are no controlled data in human pregnancy. Poorly controlled diabetes during pregnancy is associated with increased risk for major birth defects, still birth, and macrosomia related mortality 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.

Use is not recommended during the second and third trimesters of pregnancy AU TGA pregnancy category: D US FDA pregnancy category: Not Assigned Risk Summary: Animal data has shown adverse renal effects with administration 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

Empagliflozin Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

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 in utero 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

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Jardiance (empagliflozin)." Boehringer Ingelheim, Ridgefield, CT.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Jardiance (empagliflozin)." Boehringer Ingelheim, Ridgefield, CT.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide