Is the use of insulin lispro safe in pregnancy?

To provide a review of the use and safety of insulin lispro during pregnancy.

This is a review of the available literature on the use of insulin lispro in pregnancy. A MEDLINE search was performed which included published manuscripts and abstracts in the English language to June 2001.

The extensive search revealed that data on insulin lispro use during pregnancy are limited. Most of the reports on the use of insulin lispro during pregnancy demonstrated improvement of glycemic control, an increase in patient satisfaction, decreased hypoglycemic episodes, improved maternal and neonatal outcomes, and no deterioration in retinal status. However, there were two reports where it was suggested that there was an association with the use of insulin lispro in pregnancy and increased risk for the development of congenital anomalies and/or development or progression of diabetic retinopathy.

Preliminary data suggest that insulin lispro does not have adverse maternal or fetal effects during pregnancy in women with diabetes. The use of insulin lispro during pregnancy results in improved glycemic control, fewer hypoglycemic episodes, improved patient satisfaction, improved maternal and neonatal outcomes and no deterioration in retinal status. There is no evidence that the use of insulin lispro during pregnancy results in an increased rate of congenital malformations. A prospective randomized clinical trial is imperative for further evaluation of any possible association with the use of insulin lispro during pregnancy and an increased rate of congenital malformations or change in retinal status.