NovoLog Mix 70/30 and Pregnancy: An Overview
NovoLog Mix 70/30 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.
NovoLog Mix 70/30 has not been studied in pregnant women or animals. However, the rapid-acting insulin (
insulin aspart, NovoLog
®) in NovoLog Mix 70/30 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 thought that insulins do not cross the placenta, it is now known that some insulins, in some circumstances, may cross the placenta.
Some healthcare providers are uncomfortable recommending any of the newer insulins that have not been studied in pregnant women, including NovoLog Mix 70/30, 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.
