No adequate and well-controlled studies have been conducted with dulaglutide during pregnancy; use only if clearly needed and the benefit justifies the potential risk to the fetus. A drug-associated risk for major birth defects or miscarriage cannot be determined. Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide during pregnancy. In rats and rabbits, dulaglutide administered during the major period of organogenesis produced fetal growth reductions and/or skeletal anomalies and ossification deficits in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide. Increases in post-implantation loss also were observed in pregnant rats given dulaglutide. Female offspring of maternal rats who were given dulaglutide had a longer mean escape time and a higher mean number of errors relative to concurrent control during 1 of 2 trials in the memory evaluation portion of the Biel water maze. The human relevance of these memory deficits in female rats is not known. The American College of Obstetricians and Gynecologists (ACOG) and the American Diabetes Association (ADA) continue to recommend human insulin as the standard of care in women with diabetes or gestational diabetes mellitus (GDM) requiring medical therapy; insulin does not cross the placenta.
Diabetic patients must follow a regular, prescribed diet and exercise schedule to avoid either hypo- or hyperglycemia. Fever, thyroid disease, infection, recent trauma or surgery, diarrhea secondary to malabsorption, vomiting, and certain medications can affect requirements of antidiabetic agents; dosage adjustments may be necessary. Diabetic patients should be given a 'sick-day' plan to take appropriate action with blood glucose monitoring and their antidiabetic therapy, including liraglutide, when acute illness is present. Temporary use of insulin in place of oral antidiabetic agents may be necessary during periods of physiologic stress (., burns, systemic infection, trauma, surgery, or fever).