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Nateglinide Pregnancy and Breastfeeding Warnings

Nateglinide is also known as: Starlix

Nateglinide Pregnancy Warnings

Adverse effects on the embryonic development of rabbits have been observed and the incidence of gallbladder agenesis or small gallbladder was increased with doses approximately 40 times expected human exposure. This drug was not teratogenic in rats. There are no adequate and well-controlled studies in pregnant women. 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.

Use is not recommended US FDA pregnancy category: C

See references

Nateglinide Breastfeeding Warnings

Use is not recommended Excreted into human milk: Unknown Excreted into animal milk: Yes

Due to lack of information on the use of this drug during lactation, an alternate drug may be preferred. Studies in lactating rats have shown this drug is excreted into milk with a milk to plasma ratio of approximately 1:4

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Starlix (nateglinide)" Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. "Product Information. Starlix (nateglinide)" Novartis Pharmaceuticals, East Hanover, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  4. Cerner Multum, Inc. "Australian Product Information." O 0

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