Overall Risk of Birth Defects Low With Ondansetron Exposure, Review Concludes

Ondansetron-exposed neonates may have small increase in incidence of cardiac abnormalities
Ondansetron-exposed neonates may have small increase in incidence of cardiac abnormalities

HealthDay News — The offspring of women using ondansetron early in pregnancy for nausea and vomiting of pregnancy or hyperemesis gravidarum may be at risk for cardiac abnormalities, although the overall risk of birth defects associated with exposure appears low, according to a review published in the May issue of Obstetrics & Gynecology.

Shaun D. Carstairs, MD, from the University of California in San Diego conducted a systematic literature review to examine the risk of birth defects in children born to women who used ondansetron early in pregnancy. Eight records met the criteria for review.

Carstairs found that data from the studies were conflicting: the three largest studies showed no increased risk of birth defects (odds ratios of 1.12 [95% confidence interval, 0.69 to 1.82], 1.3 [95% confidence interval, 1.0 to 1.7], and 0.95 [95% confidence interval, 0.72 to 1.26]). In two of these studies the risk of cardiac defects was slightly increased (odds ratios, 2.0 [95% confidence interval, 1.3 to 3.1] and 1.62 [95% confidence interval, 1.04 to 2.14]); this finding was not replicated in other studies. There was a small increase in the incidence of cardiac abnormalities, mainly septal defects.

"The overall risk of birth defects associated with ondansetron exposure appears to be low," Carstairs writes. "There may be a small increase in the incidence of cardiac abnormalities in ondansetron-exposed neonates."

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