Safety of GLP-1 Receptor Analogues in Pregnancy: Initial Real-World-Evidence

Department of Epidemiology Seminar Series

Open to the public

Speaker:

Sonia Hernández-Díaz, MD, DrPH
Professor of Epidemiology
Department of Epidemiology
Harvard T.H. Chan School of Public Health

Short abstract: Obesity and diabetes are among the most common medical complications in pregnancy, known to increase the risk of multiple adverse perinatal outcomes. Outside of pregnancy, glucagon-like peptide-1 (GLP-1) receptor analogues have gained wide acceptance due to their efficacy and tolerability when compared to other treatment strategies. Periconceptional exposure to GLP-1 receptor analogues is increasing exponentially in the United States. Given that nearly half of pregnancies are unplanned, women inadvertently conceive while on these medications. As pregnant women are typically excluded from clinical trials, their safety for the developing fetus is unknown. Therefore, we need timely information based on carefully conducted large observational studies. We will present results from an international cohort of more than 3.5 million pregnancies; and will discuss the opportunities and challenges of using real-world data for post-approval drug safety studies in pregnancy.

Short bio: Sonia Hernández-Díaz, MD, DrPH is a Professor of Epidemiology at the Harvard T.H. Chan School of Public Health, where she serves as Director of the Pharmacoepidemiology & Real World Evidence (RWE) Program.  Her research focuses on the evaluation of drug safety during pregnancy. She has experience with case-control surveillance studies, pregnancy registries, and pregnancy cohorts nested within healthcare utilization data. Examples of her work include inquiries of the teratogenic effects of antiseizure medications, antidepressants, antipsychotics, antiretrovirals, opioids, and vaccines in pregnancy. Another group of research activities concerns the application of innovative methodologic concepts to increase the efficiency and the validity of epidemiologic studies. Dr. Hernández-Díaz has served as chair for the Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration, as member of the NICHD Pregnancy & Neonatology (PN) Study Section, and as member of the Teratogenic Information Services (TERIS) Advisory Board. She was elected President of the Society for Perinatal and Pediatric Epidemiology and President of the International Society for Pharmacoepidemiology.