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Ondansetron Not Linked to Adverse Fetal Outcomes
Findings in large cohort of women exposed to ondansetron during both early and mid-pregnancy

WEDNESDAY, Feb. 27 (HealthDay News) -- Administration of ondansetron for treatment of nausea during pregnancy is not associated with any increased risk of adverse fetal outcomes, according to a study published in the Feb. 28 issue of the New England Journal of Medicine.

To examine the risk of adverse fetal outcomes linked to ondansetron given during pregnancy, Björn Pasternak, M.D., Ph.D., from Statens Serum Institut in Denmark, and colleagues analyzed data from a historical cohort of 608,385 pregnancies including women who were exposed to ondansetron and those who were not exposed in a 1:4 ratio. The risk of spontaneous abortion, stillbirth, any major birth defect, preterm delivery, and birth of infants at low birth weight and small for gestational age were assessed in propensity-score-matched analyses.

The researchers found that exposure to ondansetron was not associated with a significantly increased risk of spontaneous abortion during gestational weeks 7 to 12 or during weeks 13 to 22. There was also no significantly increased risk of stillbirth, any major birth defect, preterm delivery, delivery of a low-birth-weight infant, or delivery of a small-for-gestational-age infant associated with receipt of ondansetron.

"Although these results cannot definitively rule out the possibility of adverse effects in association with ondansetron, the results do provide reassurance regarding the use of this agent for nausea and vomiting in pregnancy," the authors write.

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