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Clopidogrel Pregnancy and Breastfeeding Warnings

Clopidogrel is also known as: Plavix

Medically reviewed on Jul 20, 2018

Clopidogrel Pregnancy Warnings

AU and UK: Use is not recommended
US: Use during pregnancy only if clearly needed

AU TGA pregnancy category: B1
US FDA pregnancy category: B

While this drug is known to cross the placenta, animal studies have failed to reveal evidence of fetal harm. Reproduction studies performed in rats and rabbits at doses of 500 and 300 mg/kg/day (65 and 78 times the recommended daily human dose, respectively, on a mg/m2 basis) revealed no evidence of impaired fertility or fetotoxicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

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

Clopidogrel Breastfeeding Warnings

AU: Use is contraindicated
US and UK: Breastfeeding is not recommended during the use of this drug.

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. Plavix (clopidogrel)." 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

References for breastfeeding information

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

Further information

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

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