The need for appropriate registration of pregnancy outcomes under newer oral glucose‐lowering therapies

• Published in: Diabetes, obesity & metabolism Vol. 20; no. 10; pp. 2477 - 2480
• Main Authors: Benhalima, Katrien, Mathiesen, Elisabeth R., Paldanius, Päivi M., Mathieu, Chantal
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.10.2018; Wiley Subscription Services, Inc
• Subjects: Administration, Oral; Adult; Adverse Drug Reaction Reporting Systems - statistics & numerical data; Adverse Drug Reaction Reporting Systems - supply & distribution; antidiabetic drugs; Antidiabetics; Blood glucose; database research; Databases, Factual - standards; Databases, Factual - statistics & numerical data; Databases, Factual - supply & distribution; Diabetes; Diabetes mellitus; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - epidemiology; Drugs, Investigational - administration & dosage; Drugs, Investigational - adverse effects; Female; Glucose; Health Services Needs and Demand; Humans; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Infant, Newborn; outcomes; Pregnancy; Pregnancy in Diabetics - drug therapy; Pregnancy in Diabetics - epidemiology; Pregnancy Outcome - epidemiology; Research Design; safety; type 2 diabetes; type 2 diabetes; outcomes; antidiabetic drugs; safety; database research; pregnancy
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.13386

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.