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Glimepiride / rosiglitazone Pregnancy and Breastfeeding Warnings

Brand names: Avandaryl

Glimepiride / rosiglitazone Pregnancy Warnings

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

-Prolonged severe hypoglycemia (4 to 10 days) has been reported in neonates born to mother receiving a sulfonylurea at the time of delivery.
-Adequate contraception should be recommended in premenopausal women.

US FDA pregnancy category: C

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.

See references

Glimepiride / rosiglitazone Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue this drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown (glimepiride); Unknown (rosiglitazone)
Excreted into animal milk: Yes (glimepiride); Yes (rosiglitazone)

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Product Information. Avandaryl (glimepiride-rosiglitazone). GlaxoSmithKline. 2005.

References for breastfeeding information

  1. Product Information. Avandaryl (glimepiride-rosiglitazone). GlaxoSmithKline. 2005.
  2. United States National Library of Medicine. Toxnet. Toxicology Data Network. 2013.

Further information

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