FDA Approves the change of pregnancy classification of Levemir

Source: China Council for the promotion of drugs 2012-04-05 US Food and Drug Administration (FDA) approved Levemir (insulin of Dieter [rDNA source] injection) of Novo Nordisk company as pregnancy category B, which indicates that pregnant women with diabetes will not increase the risk of harm to unborn babies when using Levemir Label update makes Levemir the first basic insulin analogue to enter class B Prior to this decision, NPH (human insulin) was considered the standard of care for gestational diabetes The FDA's approval of Levemir for class B was based on a large-scale randomized controlled study examining the effect of Levemir on pregnant women with type 1 diabetes The study compared the safety and efficacy of Levemir with insulin in 310 women The study found that compared with patients taking NPH, patients taking Levemir had a decrease in A1C similar to NPH at 36 weeks of gestation, and a rapid decrease in fasting blood glucose levels at 24 and 36 weeks of gestation In addition, the study found that there was no significant difference in the safety of the two in terms of pregnancy, the end of pregnancy and the health of the fetus and the newborn Original link: http://