Ondansetron in Pregnancy and the Risk of Congenital Malformations: A Systematic Review

Journal of Obstetrics and Gynaecology Canada : JOGC = Journal D'obstétrique Et Gynécologie Du Canada : JOGC
Melissa LavecchiaSue Ross

Abstract

Ondansetron, not approved for use in pregnancy, is increasingly being prescribed for nausea and vomiting in pregnancy and hyperemesis gravidarum. A number of recent lawsuits have highlighted the possibility that ondansetron may cause congenital malformations. The aim of this study was to systematically review epidemiological evidence on the potential association of prenatal exposure to ondansetron and congenital malformations. Systematic searches in Medline and Embase were performed in June 2017 using controlled vocabulary and key words, and references of search results were reviewed. Full papers (RCTs, cohort, and case-control studies) were eligible for inclusion if they reported fetal outcomes of prenatal ondansetron exposure in humans. Excluded were: case reports, studies involving pre-medication with ondansetron prior to CS, animal studies, and foreign languages studies. Ten epidemiologic studies were included: five large retrospective cohort studies, two prospective observational studies, two population-based case-controls. and a retrospective case series. Sample sizes ranged from 17 to 1 501 434 infants exposed to ondansetron. A case-control study identified an association between prenatal exposure to ondansetron and clef...Continue Reading

Citations

Aug 23, 2019·Asia-Pacific Journal of Clinical Oncology·Naomi Eastwood-WilshereAdam Morton
Aug 2, 2020·Pediatrics·Katherine E MacDuffieBenjamin S Wilfond

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