Glimepiride / pioglitazone Pregnancy and Breastfeeding Warnings

Brand names: Duetact

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

Glimepiride / pioglitazone Pregnancy Warnings

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

US FDA pregnancy category: Not Assigned

Risk Summary: Prolonged severe hypoglycemia (4 to 10 days) has been reported in neonates born to mothers receiving a sulfonylurea at the time of delivery. Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, still birth, and delivery complications. Fetal risks of poorly controlled diabetes include major birth defects, still birth, and macrosomia related morbidity.

Comments:
-If used during pregnancy, discontinue at least 2 weeks before expected delivery; observe neonates for hypoglycemia and respiratory distress; manage accordingly.
-Adequate contraception should be recommended in premenopausal women.

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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Glimepiride / pioglitazone 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: Pioglitazone (Unknown); Glimepiride (Unknown)
Excreted into animal milk: Pioglitazone (Yes); Glimepiride (Yes)

Comments: The effects in the nursing infant are unknown.

See references

Further information

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