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Rosiglitazone Pregnancy and Breastfeeding Warnings

Rosiglitazone is also known as: Avandia

Medically reviewed on Jan 4, 2018

Rosiglitazone Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

Comments: Premenopausal anovulatory women may be at risk for pregnancy; these women should be informed of pregnancy risk.

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

Abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities, neonatal morbidity, and mortality. It is important to achieve strict normoglycemia during pregnancy. The use of insulin is generally recommended during pregnancy. 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.

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.

See references

Rosiglitazone Breastfeeding Warnings

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. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Avandia (rosiglitazone)" SmithKline Beecham, Philadelphia, PA.

References for breastfeeding information

  1. 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 -]):
  2. "Product Information. Avandia (rosiglitazone)" SmithKline Beecham, Philadelphia, PA.
  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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