April 16, 2020

Association of Maternal First-Trimester Ondansetron Use with Cardiac Malformations and Oral Clefts in Newborns

Background Information: Nausea and vomiting during pregnancy most commonly occurs during the first trimester. If left untreated, the development of hyperemesis gravidarum can lead to further complications characterized by dehydration and electrolyte abnormalities.¹ Ondansetron, a 5-HT3 receptor antagonist has quickly become the most frequently prescribed drug in the United States for nausea and vomiting during pregnancy.² With the creation of an oral dissolving tablet in 2006, Ondansetron’s popularity as an antiemetic continues to rise. In fact, a study from 2014 shows that nearly a quarter of all pregnant women in the United States are using it.³ There is uncertainty in the literature as to the association between Ondansetron and birth defects. While some studies report there is no increased risk in congenital abnormalities among women who took this antiemetic early in pregnancy, other evidence suggests it may be associated with cleft palate and cardiac malformations.² The authors of this study sought to investigate the association between exposure to Ondansetron during the first trimester of pregnancy and risk of congenital malformations in newborns using a national cohort of publicly insured pregnant women....Read More