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Medication Safety in Pregnancy

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Insulin analogues use in pregnancy among women with pregestational diabetes mellitus and risk of congenital anomaly: a retrospective population-based cohort study

Since the use of insulin analogs in the treatment of diabetes has been growing, and there is as yet little safety evidence about their use in pregnancy, the aim of this study was to evaluate the risk of major congenital anomaly associated with first-trimester exposure to insulin analogues compared with human insulin. A disease cohort of pregnant women with (pregestational) diabetes in seven European regions 1996-2012 was established retrospectively and linked to the EUROCAT congenital anomaly registries in those regions. The risk of major congenital anomaly, especially congenital heart disease, in fetuses exposed to insulin analogues was found to be lower than in those exposed to human insulin.