Pregnancies complicated by hypoglycemia and hyperglycemia pose an increased risk of birth defects, pregnancy loss, or other adverse events. Patients with diabetes or a history of gestational diabetes should maintain good metabolic control before conception and during pregnancy. Insulin requirements may decrease during the first trimester; generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential.

AU TGA pregnancy category: Not assigned; this class of drugs is generally exempt from pregnancy classification.

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.

Use is considered acceptable

AU TGA pregnancy category: Not assigned
US FDA pregnancy category: B

Comment: It is essential for patients with diabetes or a history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy.

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Exogenous insulins, including the newer biosynthetic insulins (i.e. aspart, detemir, glargine, glulisine, lispro) appear to be excreted into breast milk. Insulin is a protein that is inactivated if taken by mouth. If absorbed, it would be destroyed in the digestive tract of the infant.

Lactation onset occurs later in women with type 1 diabetes, and there is an even greater delay in those with poor glucose control. However, once established lactation persists as long in mothers with diabetes as in mothers without. Insulin requirements are generally lower in women who breastfeed, most likely due to glucose being used for milk production.

Use is considered acceptable

Excreted into human milk: Yes

Comment: Breast-feeding mothers may require adjustments in insulin dose.

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