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Levemir Approved for Use in Pregnant Women with Diabetes

Published: 4/30/12

We are encouraged to report that the FDA has approved Levemir for use in pregnant women with type 1, type 2, or gestational diabetes. Levemir is a long acting, or “basal” insulin analog made by Novo Nordisk. The FDA approval was based on a study that showed that Levemir is safe to use in pregnant women and does not appear to be associated with a risk of birth abnormalities. Both the study and the decision are important steps forward in helping women manage their diabetes during pregnancy. Strict glycemic control is especially important during pregnancy because abnormal glucose levels increase the risk of miscarriages and complications for the mother as well as birth defects and low birth weight for the infant. Currently, most women without an insulin pump use NPH (intermediate-acting human insulin), which is usually taken twice a day. Since Levemir is a steadier and longer-acting insulin treatment, it is sometimes taken only once a day, though some also take it twice daily. The insulin has also been associated with a smaller risk of hypoglycemia and may provide better glycemic control relative to NPH. We are eager to see how this more convenient and potentially more effective treatment will improve maternity care for US women who get pregnant each year and either have or get diabetes. –NR

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