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NovoLog Mix 50/50 and Pregnancy

Since no human studies have been conducted on NovoLog Mix 50/50 and pregnancy, many healthcare providers are uncomfortable recommending this form of insulin to pregnant women. The rapid-acting insulin component of the medication has been studied in animals, however, and did not cause any problems. If you are using NovoLog Mix 50/50 and pregnancy occurs, talk to your healthcare provider about any potential risks.

Using NovoLog Mix 50/50 During Pregnancy: An Overview

NovoLog® Mix 50/50 (insulin aspart protamine/insulin aspart) is a prescription diabetes medication. At this time, it is not clear if NovoLog Mix 50/50 or any of the other relatively new insulins are safe for use during pregnancy.
 
Some healthcare providers are uncomfortable recommending any of the newer insulins that have not been studied in pregnant women, including NovoLog Mix 50/50, 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.
 

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.
 
NovoLog Mix 50/50 has not been studied in pregnant women or animals. However, the rapid-acting insulin (insulin aspart, NovoLog®) in NovoLog Mix 50/50 has been studied in animals and does not appear to increase the risk of any problems, compared to regular human insulin. In general, any problems that were seen were caused by low blood sugar in the mother animals. Although it was once thought that insulins do not cross the placenta, it is now known that some insulins, in some circumstances, may cross the placenta. It is not clear if NovoLog Mix 50/50 crosses the placenta.
 
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