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
OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
Jointly provided by
NOT ENOUGH CME HOURS
It appears you don't have enough CME Hours to take this Post-Test. Feel free to buy additional CME hours or upgrade your current CME subscription plan