Levemir and Pregnancy

It is unclear if Levemir (insulin detemir) is safe for use during pregnancy. Levemir has been shown to increase the risk of various birth defects when given to pregnant animals. However, the drug has not been adequately studied in pregnant women. If you are using Levemir during pregnancy, talk to your healthcare provider about your insulin requirements, as they may change during the course of your pregnancy.

 

Levemir and Pregnancy: An Overview

Levemir® (insulin detemir) is a prescription diabetes medication used to treat type 1 and type 2 diabetes. It is a long-acting form of insulin. It is not clear if Levemir is safe for use during pregnancy.
 

Levemir and Pregnancy Category C

The U.
 S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a "default" pregnancy Category C rating.
 
In animal studies, Levemir increased the risk of various birth defects. However, in these studies, regular human insulin also increased the risk of birth defects, and it appears that Levemir is probably as safe as regular human insulin -- at least in animals. The drug has not been adequately studied in any pregnant women. Although it was thought that insulins do not cross the placenta, it is now known that some insulin, in some circumstances, may cross the placenta. However, it is not known if Levemir in particular can cross the placenta.
 
Some healthcare providers are uncomfortable recommending any of the newer insulins that have not been studied in pregnant women, including Levemir, to pregnant women. However, many healthcare providers make the logical assumption that the new insulins are just as safe (and usually more convenient) than the older insulins. This is a decision that you and your healthcare provider must make together.
 
If you are already taking Levemir and plan to continue taking it during pregnancy, you should be aware that pregnancy usually affects your insulin requirements. You likely will need more insulin during pregnancy, especially during the last trimester. As a pregnant woman with diabetes, you will need more prenatal care than the average pregnant woman.
 
(Levemir and Pregnancy Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;