Developed in 1991, the anti-nausea drug Zofran, generic name ondanestron, is a 5-HT3 receptor antagonist drug, which blocks against serotonin. While the drug was originally intended for use in cancer patients suffering from the effects of chemotherapy, the drug has been given to pregnant women for years to treat NVP, or severe vomiting and nausea of pregnancy. The drug is not approved for use for NVP in the United States, but Zofran and pregnancy often go hand-in-hand due to a lack of other anti-nausea drugs. New studies, though, speak to the dangers of using ondanestron during pregnancy.

Research in 2012 About the Effects of Zofran Limited

In 2012, Gideon Koren published a study in the journal Canadian Family Physician stating that research about the effects of Zofran during pregnancy “was based on fewer than 200 births” at that point. Koren also stated that a more recent case study about the drug linked the use of ondanestron during pregnancy to a higher risk of cleft palate. Koren concluded that the drug should not be considered safe for use during pregnancy.

The study also stated — which was acknowledged and published by the FDA in a 2012 safety announcement — that this drug’s use had been linked with a change in the electrical heart rate of the patient taking the drug (not the fetus), which could then develop into an abnormal, and potentially fatal, heart rate known as Torsades de Pointes.

Recent Study Confirms Koren’s Findings

Despite the publication of Koren’s research in 2012 linking Zofran to an increased risk of birth defects and concluding that the drug was not safe for use during pregnancy, many health care providers continued to prescribe the drug to pregnant women. In December 2014, the American Journal of Obstetrics & Gynecology published a report titled, “Use of ondanestron during pregnancy and congenital malformations in the infant.” The research concluded that there was an association of the use of this drug during pregnancy and the development of cardiovascular defects, such as septum defects, in the fetus. What’s more, the report also stated, “Ondanestron should not be used off label for nausea and vomiting in early pregnancy.” None of the infants involved in the study who were exposed, had a cleft lip/palate.

Conflicting Reports Regarding Zofran Safety

While multiple research suggests that using Zofran during pregnancy may be dangerous for both mom and baby, there are still advocates of Zofran who claim that ondanestron during pregnancy is not associated with an increased risk of fetal harm. Until more conclusive evidence is published, the jury is still out, so to speak, regarding the true risks of taking the drug while pregnant. In fact, a study in the New England Journal of Medicine published as recently as 2013 states that there is no increased risk of harm to a developing fetus if the mother takes the drug.

My baby was born with a defect after I took Zofran during pregnancy – what should I do?

Ondanestron has not been approved for use during pregnancy; rather, it is specifically intended for use during cancer chemotherapy, radiation and therapy. As such, if a doctor has suggested that you take Zofran during pregnancy to reduce NVP, and if the drug causes you or your baby harm, you may have a claim for damages.

At Gacovino, Lake & Associates, P.C., our attorneys are aware of the dangers during pregnancy and want to make sure that your rights are protected if the drug has harmed your or your child. You can learn more about how to file a medical malpractice suit for damages or a lawsuit against the manufacturer by contacting us today at 800-550-0000.

Additional Information:

Zofran Side Effects Linked to Birth Defects