The majority of pregnant women take prescribed medication. However, for many medications there is limited knowledge of the efficacy and safety for both the woman and fetus. Pregnant women are largely excluded from clinical trials and post-marketing surveillance has been scarce and inadequate thus far. Therefore, we must rely on studies based on observational data to provide evidence for health professionals and pregnant women to make informed decisions on their treatments.
Among women of childbearing age, diabetes mellitus has become an increasingly important public health problem in the last decades. Consequently, type 2 diabetes is now one of the most common disorders complicating pregnancy. Poorly controlled type 2 diabetes has been associated with significant maternal, fetal, and neonatal morbidity and mortality. Therefore, there is an increasing demand for safe and effective antidiabetic medication (ADM) for use in pregnancy.
Therefore, the overall objective of this fellowship was to assess the safety of the medications used to treat type 2 diabetes by investigating the risk of major malformations in infants prenatally exposed to metformin and to newer 2nd line non-insulin antidiabetic medications including sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) analogues, and sodium-glucose co-transporter 2 (SGLT2) inhibitors. This objective was achieved by using data from US insurance claims databases, health care data from Israel, and the Nordic population health registers within the International Pregnancy Safety Study consortium (InPreSS). Combined, these sources include data for an unprecedented number of pregnant women for use in these high-quality pharmacoepidemiological observational research studies.
