ArticleInternational journal of epidemiology2020
Ondansetron use in the first trimester of pregnancy and the risk of neonatal ventricular septal defect.
Article in International journal of epidemiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.
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Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.
- Risk of abnormal pregnancy outcomes after using ondansetron during pregnancy: A systematic review and meta-analysis.Frontiers in pharmacology · 2022Pooled it
- Comparison of Pregnancy Outcomes of Patients Treated With Ondansetron vs Alternative Antiemetic Medications in a Multinational, Population-Based Cohort.JAMA network open · 2021Pooled it
- Pharmacovigilance signals for congenital heart disease related to drug exposure: A disproportionality analysis based on the FAERS database.American heart journal plus : cardiology research and practice · 2026Article
- A Scoping Review of 5-HTPharmacoepidemiology and drug safety · 2026Article
- Cancer in Pregnancy: Therapeutic Decisions at the Intersection of Two Lives.Diagnostics (Basel, Switzerland) · 2026Review
- Real-world pharmacological treatment of patients with hyperemesis gravidarum in 9 cities of China from 2019 to 2024: a cross-sectional analysis.Frontiers in pharmacology · 2026Article
- Identifying medication use clusters with the R package tame based on dose, timing and ATC codes.Scientific reports · 2025Article
- In Vitro Models of Cardiovascular Disease: Embryoid Bodies, Organoids and Everything in Between.Biomedicines · 2024Review
- Article
- A patterned human primitive heart organoid model generated by pluripotent stem cell self-organization.Nature communications · 2023Article
- Ondansetron use in nausea and vomiting during pregnancy: A descriptive analysis of prescription patterns and patient characteristics in UK general practice.British journal of clinical pharmacology · 2022Article
- Longitudinal Methods for Modeling Exposures in Pharmacoepidemiologic Studies in Pregnancy.Epidemiologic reviews · 2022Review
- Patterns of antiemetic medication use during pregnancy: A multi-country retrospective cohort study.PloS one · 2022Article
- Antiemetic Prescription Fills in Pregnancy: A Drug Utilization Study Among 762,437 Pregnancies in Norway.Clinical epidemiology · 2021Article
Corrections and comments
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Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundLiterature is divided regarding the risk of neonatal ventricular septal defect (VSD) associated with first trimester ondansetron use in pregnancy.
methodsWe evaluated the risk of VSD associated with first trimester exposure to intravenous or oral ondansetron in 33 677 deliveries at Magee-Womens Hospital in Pittsburgh, PA (2006-2014). Using log-binomial regression, we evaluated the risk: (1) in the full cohort, (2) using propensity score designs with both matching and inverse probability weighting and (3) utilizing clustered trajectory analysis evaluating the role of dose. Sensitivity analyses assessed the association between ondansetron and all recorded birth defects in aggregate.
resultsA total of 3733 (11%) pregnancies were exposed to ondansetron in the first trimester (dose range: 2.4-1008 mg). Ondansetron was associated with increased risk of VSD with risk ratios ranging from 1.7 [95% confidence interval (CI) 1.0-2.9] to 2.1 (95% CI 1.1-4.0) across methods. Risks correspond to one additional VSD for approximately every 330 pregnancies exposed in the first trimester. The association was dose-dependent with increased risk in women receiving highest cumulative doses compared with lowest doses [adjusted risk ratio: 3.2 (95% CI 1.0-9.9)]. The association between ondansetron and congenital malformations was diluted as the outcome included additional birth defects.
conclusionsFirst trimester ondansetron use is associated with an increased risk of neonatal VSD potentially driven by higher doses. This risk should be viewed in the context of risks attributable to severe untreated nausea and vomiting of pregnancy.
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