Funding information K. B. is the recipient of a Clinical DoctoralScholarship of the academic fund of UZ Leuven.Because of the increase in type 2 diabetes (T2DM) in young adults, women of childbearing age are frequently treated with newer glucose-lowering therapies, and an increase in unintentional exposure to therapies unapproved for use during pregnancy is expected. The clinician is left with the dilemma of deciding between discontinuation of a novel agent that is providing excellent glycaemic control, while switching to other agents may cause deterioration of glycaemia, and continued use of novel agents that may have uncertain effects on the unborn child. For T2DM, pregnancy data are collected only via spontaneous reporting systems. Therefore, we evaluated the available data on pregnancy outcomes under newer glucose-lowering agents in pharmaceutical safety databases. We found that data on pregnancy outcomes with new glucose-lowering agents in T2DM are scarce, with a high risk of bias towards negative outcomes, limiting their usefulness in robustly assessing safety. Because of the lack of information at present, these agents are not recommended for use during pregnancy or when planning pregnancy. To better guide clinical practice, structured systems of assessing pregnancy outcomes in women receiving these novel agents are urgently needed.antidiabetic drugs, database research, outcomes, pregnancy, safety, type 2 diabetes 1 | INTRODUCTION As type 2 diabetes (T2DM) becomes more prevalent and affects a younger population, the number of women of childbearing age with T2DM will increase. In many countries, the proportion of pregnant women with T2DM has risen to nearly half of all pregnant women with diabetes, with T2DM pregnancies outnumbering type 1 diabetes (T1DM) pregnancies in some metropolitan areas. 1 Women with T2DM are at equally high risk as those with T1DM of adverse pregnancy outcomes such as congenital anomalies and stillbirths. 1 Preconception care, with the aim of optimizing glycaemic control, can reduce adverse pregnancy outcomes. 1 While preconception care for women with T1DM is facilitated through follow-up at diabetes services, women with T2DM often fail to take advantage of this available care.In addition, many pregnancies in women with T2DM are unplanned. 2,3 Because of the potential implications of transplacental passage of oral glucose-lowering agents for the developing fetus, and because of the long-standing experience and efficacy of insulin during pregnancy, insulin is generally recommended as the first-choice treatment during pregnancy to achieve good glycaemic control. 4 Experience with oral hypoglycaemic agents, such as metformin and glibenclamide, during pregnancy mostly concerns women with gestational diabetes. 5,6 In addition, there is a paucity of long-term follow-up data on children exposed to these agents in utero. 7 Recent data suggest significantly increased rates of overweight and obesity in a cohort of 4-year-old children of mothers with polycystic ovarian syndrome who were expose...