Review: Low Risk of Birth Defects With Ondansetron Exposure

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Review: Low Risk of Birth Defects With Ondansetron Exposure
Review: Low Risk of Birth Defects With Ondansetron Exposure

WEDNESDAY, April 13, 2016 (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, M.D., 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 percent confidence interval, 0.69 to 1.82], 1.3 [95 percent confidence interval, 1.0 to 1.7], and 0.95 [95 percent 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 percent confidence interval, 1.3 to 3.1] and 1.62 [95 percent 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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