First trimester ondansetron exposure and risk of structural birth defects

Zambelli-Weiner, April; Via, C; Yuen, M; Weiner, Daniel J.; Kirby, Russell S.

doi:10.1016/j.reprotox.2018.10.010

Cited by 47 publications

(59 citation statements)

References 35 publications

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“…The diagnosis in the prenatal period carries a poor prognosis for both fetus and neonate [10]. In many centres in the world, pregnant women diagnosed with Ebstein's syndrome in the fetus choose the option of termination of pregnancy [19].…”

Section: Discussionmentioning

confidence: 99%

“…Another recent study investigated the risk of specific structural birth defects associated with ondansetron exposure during the first trimester in a large, US, commercially insured population including 864,083 mother-infant pairs from 2000 to 2014 [19]. 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 when compared to women with no antiemetic exposure during pregnancy.…”

Section: Ondansetronmentioning

confidence: 99%

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Cardiac birth defects induced by maternal medications

Koren¹

2020

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Cardiovascular malformations form the largest group of congenital anomalies, typically quoted at 0.8% of all live births. Several medicinal drugs have been proven to cause cardiovascular malformations. We discuss here the risks of the major known medications, including lithium, valproic acid, ondansetron, methylphenidate, topiramate, and the newly recognised dydrogesterone. In contrast, we discuss the controversial and debated effects of selective serotonin reuptake inhibitors (SSR) and selective serotonin norepinephrine reuptake inhibitors (SNRI). Subsequently we describe the principles of counselling pregnant women and those planning pregnancy, who are exposed to these drugs.

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Section: Discussionmentioning

confidence: 99%

Section: Ondansetronmentioning

confidence: 99%

Cardiac birth defects induced by maternal medications

Koren¹

2020

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“…5,6 Huybrechts identified an increased risk of cleft lip and palate (CLP), but no increased risk of cardiac defects, 5 while Zambelli-Weiner identified an increased risk of cardiac defects; however, this study has limitations including possible selection bias and exposure/outcome misclassification as indicated by a high rate of cardiac defects observed in comparison to the background rate. 6 While Huybrechts study appears to be methodologically robust, the issue with the study is not the result (a small increase in associated CLP with ondansetron exposure) rather the interpretation of risk. The background risk of CLP is small (accounting for 11 per 10,000 pregnancies); therefore, a small increase in relative risk means that the absolute risk from ondansetron exposure during the first trimester is approximately 14 per 10,000 pregnancies.…”

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confidence: 85%

Ondansetron for nausea and vomiting in pregnancy: re-evaluating the teratogenic risk

Michie

Hodson

2020

Obstet Med

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Nausea and vomiting in pregnancy (NVP) affects up to 80% of pregnant women with more severe hyperemesis gravidarum (HG) accounting for 1.5%. 1 HG is associated with worse pregnancy outcome; however, the impact of NVP and HG on hospital admission and psychological wellbeing is substantial with 18% of women reporting post-traumatic stress and some women expressing a desire to end their pregnancy as a consequence of NVP/HG. 2

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“…2 Numerous studies have focused on the risk of birth defects and conflicting results have been published regarding the risk of cardiac and orofacial cleft defects. [3][4][5][6][7] Less attention has been paid to other pregnancy outcomes, including common but less serious adverse outcomes such as preterm birth, low birth weight, and hypertensive disorders, or rare and serious outcomes including stillbirth. The few studies evaluating these adverse outcomes in association with ondansetron use have compared women using ondansetron to a general population of pregnant women not using ondansetron, 8,9 and have not otherwise appropriately controlled for confounding.…”

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confidence: 99%

Ondansetron use in early pregnancy and the risk of late pregnancy outcomes

Suarez

Boggess

Engel

et al. 2020

Pharmacoepidemiology and Drug

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BackgroundThe effects of ondansetron, used off‐label to treat nausea and vomiting during pregnancy, on common pregnancy complications are understudied. Modest effects of a commonly used drug could result in adverse events for large numbers of pregnant women. Therefore, our objective was to compare the risk of stillbirth, preterm birth, gestational hypertensive disorders, small for gestational age, and differences in birth weight between women prescribed ondansetron and women prescribed alternative antiemetics in early pregnancy.MethodsA cohort of pregnant women receiving a prescription for ondansetron or comparator antiemetics (metoclopramide or promethazine) during the first 20 weeks of pregnancy was identified using electronic health record data from a health care system in North Carolina, USA. Confounding by multiple covariates was controlled using stabilized inverse probability of treatment weights. Weighted hazard ratios (HR) and 95% confidence intervals (CI) accounted for competing events.ResultsWe identified 2677 eligible pregnancies with antiemetic orders, 66% for ondansetron. The small number of stillbirths (n = 15) resulted in an imprecise estimate of the association with ondansetron (HR = 1.60; 95%CI 0.51, 4.97). No association was observed for preterm birth (HR = 0.90; 95%CI 0.67, 1.20) or gestational hypertensive disorders (HR = 0.87; 95%CI 0.68, 1.12). We observed an association with small for gestational age (HR = 1.37; 95%CI 0.98, 1.90), however mean birth weight among term births was similar between groups.ConclusionsOur results do not suggest that ondansetron increases the risk of preterm birth or gestational hypertensive disorders. The weak association observed between ondansetron use and small for gestational age warrants further investigation.

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First trimester ondansetron exposure and risk of structural birth defects

Cited by 47 publications

References 35 publications

Cardiac birth defects induced by maternal medications

Cardiac birth defects induced by maternal medications

Ondansetron for nausea and vomiting in pregnancy: re-evaluating the teratogenic risk

Ondansetron use in early pregnancy and the risk of late pregnancy outcomes

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