Zofran birth defect studies on all women giving birth in Denmark between 1997 and 2010 have found that women who take Zofran during early pregnancy double their risk of giving birth to a child with septal defects of the heart—holes in the walls between the heart chambers. The findings were presented on August 26, 2013, at the 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management in Montreal, Canada.
Researchers at the Sloan Epidemiology Center at Boston University, supported by a grant from the Centers for Disease Conrol and Prevention, studied nausea and vomiting during pregnancy (NVP) and the medications used to treat it. Taking ondansetron during the first trimester increased the risk of cleft palate alone by nearly two-and-a-half times. The study was published in the January 2012 issue of Birth Defects Research (Part A): Clinical and Molecular Teratology.