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• W2903907833 abstract "<h3>Importance</h3> Evidence for the fetal safety of ondansetron, a 5-HT₃receptor antagonist that is commonly prescribed for nausea and vomiting during pregnancy, is limited and conflicting. <h3>Objective</h3> To evaluate the association between ondansetron exposure during pregnancy and risk of congenital malformations. <h3>Design, Setting, and Participants</h3> A retrospective cohort study nested in the 2000-2013 nationwide Medicaid Analytic eXtract. The cohort consisted of 1 816 414 pregnancies contributed by 1 502 895 women enrolled in Medicaid from 3 months before the last menstrual period through 1 month or longer after delivery; infants were enrolled in Medicaid for at least 3 months after birth. The final date of follow-up was December 31, 2013. Analyses were conducted between November 1, 2017, and June 30, 2018. Propensity score stratification was used to control for treatment indication and other confounders. <h3>Exposures</h3> Ondansetron dispensing during the first trimester, the period of organogenesis. <h3>Main Outcomes and Measures</h3> Primary outcomes were cardiac malformations and oral clefts diagnosed during the first 90 days after delivery. Secondary outcomes included congenital malformations overall and subgroups of cardiac malformations and oral clefts. <h3>Results</h3> Among 1 816 414 pregnancies (mean age of mothers, 24.3 [5.8] years), 88 467 (4.9%) were exposed to ondansetron during the first trimester. Overall, 14 577 of 1 727 947 unexposed and 835 of 88 467 exposed infants were diagnosed with a cardiac malformation, for an absolute risk of 84.4 (95% CI, 83.0 to 85.7) and 94.4 (95% CI, 88.0 to 100.8) per 10 000 births respectively. The absolute risk of oral clefts was 11.1 per 10 000 births (95% CI, 10.6 to 11.6; 1921 unexposed infants) and was 14.0 per 10 000 births (95% CI, 11.6 to 16.5; 124 exposed infants). The risk of any congenital malformation was 313.5 per 10 000 births (95% CI, 310.9 to 316.1; 54 174 unexposed infants) and was 370.4 (95% CI, 358.0 to 382.9; 3277 exposed infants). The adjusted relative risk (RR) for cardiac malformations was 0.99 (95% CI, 0.93 to 1.06) and the adjusted risk difference (RD) was −0.8 (95% CI, −7.3 to 5.7 per 10 000 births). For oral clefts, the adjusted RR was 1.24 (95% CI, 1.03 to 1.48) and the RD was 2.7 (95% CI, 0.2 to 5.2 per 10 000 births). The adjusted estimate for congenital malformations overall was an RR of 1.01 (95% CI, 0.98 to 1.05) and an RD of 5.4 (95% CI, −7.3 to 18.2 per 10 000 births). <h3>Conclusions and Relevance</h3> Among offspring of mothers enrolled in Medicaid, first-trimester exposure to ondansetron was not associated with cardiac malformations or congenital malformations overall after accounting for measured confounders but was associated with a small increased risk of oral clefts." @default.
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• W2903907833 date "2018-12-18" @default.
• W2903907833 modified "2023-10-15" @default.
• W2903907833 title "Association of Maternal First-Trimester Ondansetron Use With Cardiac Malformations and Oral Clefts in Offspring" @default.
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• W2903907833 doi "https://doi.org/10.1001/jama.2018.18307" @default.
• W2903907833 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/6669077" @default.
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