Glimepiride Pregnancy and Breastfeeding Warnings

Brand names: Amaryl

Medically reviewed by Drugs.com. Last updated on Mar 21, 2024.

Glimepiride Pregnancy Warnings

Use is not recommended.

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

Comments:
-Severe hypoglycemia lasting 4 to 10 days has been reported in neonates born to mothers receiving a sulfonylurea at the time of delivery.
-Insulin is recommended during pregnancy to maintain blood glucose levels as normal as possible.

Animal studies have revealed evidence of fetotoxicity, most likely a result of maternal hypoglycemia. 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.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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 Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: If diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.

While the excretion of other sulfonylureas into human milk has been demonstrated, the excretion of this drug into human milk is unknown. Significant concentrations of this drug have been found in rat milk as well as the serum of pups. In rat pups exposed to high doses during pregnancy and lactation, hypoglycemia and skeletal deformities consisting of shortening, thickening, and bending of the humerus have occurred. These skeletal deformations were determined to be the result of nursing from mothers exposed to this drug.

See references

Further information

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