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

BACKGROUND

The 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.

METHODS

A 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.

RESULTS

We 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.

CONCLUSIONS

Our 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.