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. 2020 Jan 28;323(4):372-374.
doi: 10.1001/jama.2019.18587.

Intravenous Ondansetron in Pregnancy and Risk of Congenital Malformations

Krista F Huybrechts  1 , Sonia Hernandez-Diaz  2 , Loreen Straub  1 , Kathryn J Gray  3 , Yanmin Zhu  1 , Helen Mogun  1 , Brian T Bateman  1
Affiliations

Intravenous Ondansetron in Pregnancy and Risk of Congenital Malformations

Krista F Huybrechts et al. JAMA. .

Abstract

This pharmacoepidemiology study uses Medicaid data to estimate associations between first-trimester use of intravenous ondansetron and risk of cardiac malformations and oral cleft in children of exposed mothers.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Huybrechts reported receiving research grants to her institution from Eli Lilly, Pfizer, GlaxoSmithKline, and Boehringer-Ingelheim outside the submitted work. Dr Hernandez-Diaz reported receiving research grants to her institution from Eli Lilly and GlaxoSmithKline outside the submitted work; consulting fees from Roche; and serving as an epidemiologist with the North America Antiepileptic Drug Pregnancy Registry, which is funded by multiple companies. Dr Gray reported receiving personal fees from Quest Diagnostics and nonfinancial support from Illumina Inc. Dr Bateman reported receiving research grants to his institution from Eli Lilly, Pfizer, GlaxoSmithKline, Pacira, and Baxalta outside the submitted work; consulting for Aetion; and serving on an expert panel for a postpartum hemorrhage quality improvement project that was conducted by the Association of Women's Health, Obstetric, and Neonatal Nurses and funded by a grant from Merck for Mothers. No other disclosures were reported.

Figures

Figure.
Figure.. Risk of Congenital Malformations in Infants Following Exposure to Intravenous Ondansetron During the First Trimester
Relative risks and 95% CIs are presented to show the risk of any congenital malformation, cardiac malformations, and oral clefts among infants born to women with exposure to intravenous ondansetron during the first trimester compared with infants born to women without such exposure.
See this image and copyright information in PMC

Comment in

References

    1. Huybrechts KF, Hernández-Díaz S, Straub L, et al. . Association of maternal first-trimester ondansetron use with cardiac malformations and oral clefts in offspring. JAMA. 2018;320(23):2429-2437. doi:10.1001/jama.2018.18307 - DOI - PMC - PubMed
    1. Zambelli-Weiner A, Via C, Yuen M, Weiner DJ, Kirby RS. First trimester ondansetron exposure and risk of structural birth defects. Reprod Toxicol. 2019;83:14-20. doi:10.1016/j.reprotox.2018.10.010 - DOI - PubMed
    1. Palmsten K, Huybrechts KF, Mogun H, et al. . Harnessing the Medicaid Analytic Extract (MAX) to evaluate medications in pregnancy: design considerations. PLoS One. 2013;8(6):e67405. doi:10.1371/journal.pone.0067405 - DOI - PMC - PubMed
    1. Desai RJ, Rothman KJ, Bateman BT, Hernandez-Diaz S, Huybrechts KF. A propensity-score-based fine stratification approach for confounding adjustment when exposure is infrequent. Epidemiology. 2017;28(2):249-257. doi:10.1097/EDE.0000000000000595 - DOI - PMC - PubMed
    1. Huybrechts KF, Bateman BT, Hernández-Díaz S. Use of real-world evidence from healthcare utilization data to evaluate drug safety during pregnancy. Pharmacoepidemiol Drug Saf. 2019;28(7):906-922. doi:10.1002/pds.4789 - DOI - PMC - PubMed

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