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Insulin detemir Pregnancy and Breastfeeding Warnings

Insulin detemir is also known as: Levemir

Medically reviewed by Last updated on Apr 6, 2020.

Insulin detemir Pregnancy Warnings

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.

See references

Insulin detemir Breastfeeding Warnings

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.

See references

References for pregnancy information

  1. "Product Information. Levemir (insulin detemir)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Multum Information Services, Inc. Expert Review Panel"
  4. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL:" ([1999]):

References for breastfeeding information

  1. "Product Information. Levemir (insulin detemir)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  4. "Multum Information Services, Inc. Expert Review Panel"
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.