Use during pregnancy only if the potential benefit justifies the potential risk to the fetus

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

Pregnancies complicated by hyperglycemia pose an increased risk of birth defects, pregnancy loss, or other adverse events. In an open-label randomized trial in pregnant women with type 1 diabetes using basal bolus regimens of insulin detemir (n=152) or NPH insulin (n=158), no increase in fetal abnormalities were observed in the insulin detemir arm. In animal studies in rats and rabbits, the embryotoxicity and teratogenicity of insulin detemir did not differ greatly from that observed with human insulin.

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 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.

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.

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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. Insulin requirements are generally lower in women who breastfeed, most likely due to glucose being used for milk production.

Use is considered acceptable; caution is recommended.

Excreted into human milk: Yes

Comments: Women who are breastfeeding may require adjustments in insulin dose and diet.

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