Swedish Study Links Zofran (ondansetron) with High Risk of Heart Defects in Babies

A 2014 study out of Sweden, titled “Use of Ondansetron During Pregnancy and Congenital Malformations in the Infant,” investigated the risks associated with taking the anti-nausea medication Zofran (ondansetron) during a woman’s pregnancy. The study was conducted using data from the Swedish Medical Birth Register and from the Swedish Register of Prescribed Drugs, examining 1,349 infants born between 1998 and 2012 whose birth mothers had ingested Zofran during the early months of their pregnancies. Notably, the study confirmed that cardiovascular defects and cardiac septum defects were “increased and statistically significant” when the fetus was exposed to the drug in its early development.

Zofran (ondansetron) has been prescribed to moms-to-be to help cope with nausea and vomiting often occurring in the first trimester of pregnancy. The drug has not been approved by the FDA for use in pregnant women, putting children at risk for congenital heart defects and other complications such as cleft palate.

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