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Saxagliptin Pregnancy and Breastfeeding Warnings

Saxagliptin is also known as: Onglyza

Medically reviewed on Mar 7, 2017

Saxagliptin Pregnancy Warnings

This drug should be used only if clearly needed.

AU TGA pregnancy category: B3
US FDA pregnancy category: B

Comments: This drug crosses the placenta into the fetus following dosing in pregnant rats.

Animal studies have failed to reveal evidence of teratogenicity. Incomplete ossification of the pelvis, a form of developmental delay, occurred in rats at higher doses. No functional or behavioral toxicity was observed in offspring of rats at any saxagliptin dose. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Saxagliptin Breastfeeding Warnings

AU, US: Caution is recommended.
UK: 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

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Onglyza (saxagliptin)." Bristol-Myers Squibb, Princeton, NJ.

References for breastfeeding information

  1. "Product Information. Onglyza (saxagliptin)." Bristol-Myers Squibb, Princeton, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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