Merck announced an extension to the label for metformin products in the EU - Glucophage® (metformin hydrochloride [HCL] immediate release), Glucophage XR® (metformin HCL extended release) and Stagid® (metformin embonate immediate release) - for use throughout pregnancy.
In a European worksharing procedure (WSP), the variation for label extension was approved based on results from Merck’s register-based cohort safety study, investigating the follow up of children from over ~4.000 pregnancies with metformin1 for up to 11 years and extensive independent scientific publications, which all confirmed no increased risk of congenital abnormalities or feto/neonatal toxicity after exposure to metformin at the time of conception and throughout pregnancy.
The prevalence of type 2 diabetes is rising around the world.2 In 2021, 21.1 million births worldwide (16.7%) were affected by hyperglycemia.2 In Europe, 3-7% of all pregnant women develop gestational diabetes (GDM).3,4 Furthermore, 1% of all pregnancies are in women with pre-existing type 2 diabetes.5 To date, these conditions had to be managed with insulin when drugs were needed. Regarding the periconceptional phase, insulin-resistant polycystic ovary syndrome (PCOS), which affects 5-20% of all reproductive-aged women6,7,is associated with a 15-fold increase in infertility. The rate of early pregnancy loss is three times greater in PCOS.