Levemir Approved for Pregnant Women
The FDA approved Levemir for use during pregnancy. The only long acting insulin previously approved for pregnant women was NPH.
310 pregnant women with type 1 diabetes took part in a randomized control study. The results of the study have not been published so some doctors are still weary of what the approval means.
As explained in Joslin’s blog, Levemir was previously classified by the FDA as category 3: “Risk can’t be ruled out. There isn’t sufficient evidence yet one way or another but adequate human studies do not exist. The benefit of using the drug may outweigh its risks.”
It now has the same classification as NPH, category 2: “Well controlled studies have failed to demonstrate risk to the fetus despite findings to the contrary in animal studies or animal studies show no risk and human studies are lacking.”
What will you choose? NPH, Levemir or will you stick with the pump? Leave a comment.