Insulin glargine Pregnancy and Breastfeeding Warnings
Insulin glargine Pregnancy Warnings
There are no controlled data in human pregnancy, however in more than 1000 pregnancy outcomes, no specific adverse effects of insulin glargine on pregnancy and no specific malformations nor fetal or neonatal toxicity were reported. In animal studies in rats and rabbits, the effects of insulin glargine did not differ greatly from those observed with regular human insulin, although 5 fetuses from 2 litters in the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal. 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. 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.
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus AU TGA pregnancy category: B3 US FDA pregnancy category: C
Insulin glargine Breastfeeding Warnings
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.
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.
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