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Ondansetron Use in Pregnancy and Birth Defects: A Systematic Review.
1Division of Medical Toxicology, Department of Emergency Medicine, University of California, San Diego, San Diego, California.
Obstetrics and Gynecology
|April 8, 2016
Summary
Ondansetron use in early pregnancy for nausea appears to have a low overall risk of birth defects. However, a slight increase in cardiac abnormalities may occur in exposed newborns.
Area of Science:
- Obstetrics and Gynecology
- Pharmacology
- Teratology
Background:
- Nausea and vomiting of pregnancy (NVP) and hyperemesis gravidarum (HG) are common conditions.
- Ondansetron is frequently prescribed for NVP/HG, raising concerns about fetal safety.
Purpose of the Study:
- To evaluate the risk of congenital birth defects in infants exposed to ondansetron during the first trimester of pregnancy.
Main Methods:
- Systematic review of multiple databases including PubMed, EMBASE, Cochrane, Scopus, Web of Science, Journals@Ovid, ClinicalTrials.gov, and Google Scholar.
- Inclusion criteria: English language, comparison group, human data, original research, first-trimester ondansetron exposure, and structural birth defects outcome.
- Eight studies met the criteria for review.
Main Results:
- Conflicting data exists regarding overall birth defect risk; the largest studies indicated no significant increase (ORs ranging from 0.95 to 1.3).
- Two studies suggested a slightly elevated risk of cardiac defects (ORs 2.0 and 1.62), but this was not consistently replicated.
- The most consistent finding was a potential small increase in cardiac abnormalities, primarily septal defects.
Conclusions:
- The overall risk of birth defects associated with first-trimester ondansetron exposure is considered low.
- A potential small increase in cardiac abnormalities warrants consideration.
- Ondansetron should be reserved for pregnant women with NVP/HG unresponsive to other treatments.
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