期刊
REPRODUCTIVE TOXICOLOGY
卷 83, 期 -, 页码 14-20出版社
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/j.reprotox.2018.10.010
关键词
Ondansetron; Zofran; Birth defects; Congenital malformations; Congenital anomalies; Cardiac defects; Orofacial clefts; Nausea and vomiting in pregnancy
This study investigates risk of specific structural birth defects associated with ondansetron exposure during the first trimester in a large US commercially-insured population. Medical claims data were obtained from Truven Health Analytics for 864,083 mother-infant pairs from 2000 to 2014. Logistic regression was used to measure the association between first trimester exposure to ondansetron and risk of cardiac defects, orofacial clefts and other specific structural defects in offspring. First trimester exposure to ondansetron was associated with increased risk of cardiac (OR: 1.52 95% CI: 1.35-1.70) and orofacial cleft defects (OR: 1.32 95% CI: 0.76-2.28) in offspring compared to women with no antiemetic exposure during pregnancy. This analysis addresses limitations of prior studies including limited power, exposure misclassification, and generalizability to the US population. In a large, US population we found a statistically significant association between early pregnancy ondansetron exposure and specific structural birth defects in offspring.
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