Use is considered acceptable

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

Risk Summary: Available data have not reported an association with insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes; there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.

Comments:
-For women who are pregnant, and for women who are contemplating pregnancy, intensified blood glucose control and close monitoring of blood glucose is essential.

No adverse effects on embryo/fetal viability or morphology were observed in the offspring of rats exposed to insulin lispro during organogenesis and no adverse effects on embryo/fetal viability were observed in the offspring of rabbits. Published studies have not reported an association between insulin lispro and the induction of major birth defects. Pregnancies complicated by hyperglycemia pose an increased risk of birth defects and pregnancy loss. Poorly controlled diabetes increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications, and increases the fetal risk for major birth defects, stillbirth, and macrosomia related, or other adverse events. The estimated background risk of major birth defects among women with pre-gestational diabetes is 6% to 10% for those with a HbA1c less than 7% and 20% to 25% in women with a HbA1c greater than 10%. Compared to human insulin, differences in adverse effects or health of the fetus have not been shown with insulin lispro. 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 of pregnancy and increase during the second and third trimesters. There are no controlled data in human pregnancy.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

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.

See references

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

Comments:
-Proper insulin levels are necessary for lactation; good glycemic control enhances maternal serum and milk prolactin concentrations.
-Breast-feeding mothers with diabetes may require adjustments in insulin dose, diet, or both.

See references