Review Examines Safety of GLP-1/GIP Agonists During Pregnancy and Lactation

GLP-1 receptor agonists (a class of drugs that mimic a natural hormone involved in blood sugar regulation and appetite) and dual GLP-1/GIP receptor agonists are increasingly used for managing type 2 diabetes and obesity. However, there is a critical lack of comprehensive data regarding their safety during preconception, pregnancy, and lactation, leaving a significant gap for clinicians and patients navigating treatment options.

The review identified limited high-quality human data, with most evidence derived from animal studies or small observational human cohorts. Animal models, particularly at doses exceeding clinical exposure by 10-fold or more, sometimes showed increased incidences of fetal malformations (e.g., skeletal defects) or growth restriction. In human observational data, often from inadvertent exposures, a clear and consistent signal for major adverse maternal or fetal outcomes was not established, though these studies were typically underpowered. The most critical finding was the overwhelming lack of prospective, controlled human trials, making definitive safety conclusions impossible. Furthermore, data on drug transfer into breast milk and its effects on neonates were virtually non-existent, with fewer than 5 relevant studies identified across all reviewed literature.