First-Trimester Pregnancy Exposure to Modafinil and Risk of Congenital Malformations
Per Damkier, Anne Broe
Abstract
Discussion | Evidence from this national cohort of publicly insured pregnant women with confounding adjustment suggests that intravenously administered ondansetron was not associated with an increase in the risk of cardiac malformations, oral clefts, or congenital malformations overall. While the point estimate for oral clefts was lower for intravenous ondansetron compared with oral ondansetron (RR, 1.24 [95% CI, 1.03-1.48]), the CI was wide with an upper limit similar to that for oral ondansetron. Limitations of this study include the potential for residual confounding due to unmeasured or poorly measured characteristics, restriction of the cohort to live births and individuals with Medicaid, and availability of data through 2014 only. Overall, these findings suggest that ondansetron is not a major teratogen.