Ondansetron for Nausea During Pregnancy – Is There a Risk for Birth Defects?
BACKGROUND AND PURPOSE:
Ondansetron, a serotonin receptor antagonist, may be used as a last resort in women with nausea and vomiting in pregnancy
Data currently is limited regarding birth defect risk
Lavecchia et al. (Journal of Obstetrics and Gynaecology Canada, 2018) examined the association between prenatal exposure to ondansetron, to treat nausea during pregnancy, and congenital malformations
Systematic database search and extraction
RCTs, cohort, and case-control studies that reported fetal outcomes of prenatal ondansetron exposure
10 epidemiological studies out of 690 were included:
5 large retrospective cohort studies | 2 prospective observational studies | 2 population-based case-controls | 1 retrospective case series
Only 3 large population-based cohort studies that were designed to specifically evaluate the risk of ondansetron exposure and congenital malformations
Most studies evaluated exposure during the first trimester
One case-control study identified an association between prenatal exposure to ondansetron and cleft palate and another cohort study found an increased risk of cardiovascular defects
Neither of these findings were reproduced in the other studies, in particular the large population-based cohort study (including 1849 ondansetron pregnancies)
Study showing cardiovascular defects indicates that the majority of ondansetron exposure was after 56 days (following cardiac organogenesis)
Study showing clefting could be due to confounding due to exposure to multiple medications
The authors state that their “literature and rigorous independent review of all data on ondansetron use in pregnancy and the risk of congenital malformations did not yield significant safety concerns.”
Further investigation, using large prospective cohort studies, is needed to confirm these findings
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