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Empagliflozin Pregnancy and Breastfeeding Warnings

Empagliflozin is also known as: Jardiance

Empagliflozin Pregnancy Warnings

Animal studies have revealed evidence of the drug crossing the placenta and reaching fetal tissues, possibly affecting renal development and maturation. At maternally toxic doses, the drug caused malformation of limb bones in fetuses and increased embryofetal loss. Reduced body weight in offspring was observed at maternal exposures approximately 4-times the maximal clinical dose. There are no controlled data in human 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: D US FDA pregnancy category: C

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.

See references

References for pregnancy information

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

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