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Zofran and the Risk of Arrhythmia

Zofran (Ondansetron) use during pregnancy and it’s risk to developing babies has simultaneously garnered a nationwide spotlight and backlash. Additionally, Zofran can cause adverse reactions in adults, like cancer patients and pregnant women, taking the drug.

In 2011, the Food and Drug Administration (FDA) announced it was investigating reports of “abnormal changes in the electrical activity of the heart” in patients taking Zofran. The FDA instructed GlaxoSmithKline (GSK) to perform a study determining Zofran’s effects on heart activity.

The study was completed in 2012. The FDA said of the study, “preliminary results from a recently completed clinical study suggest that a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation) which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.” Torsades de Pointes can potentially lead to sudden cardiac death.

GlaxoSmithKline pulled the 32 mg dose off the market, and altered Zofran’s warning label to alert doctors and medical providers of the increased risks. Dr. Gideon Koren of the The Motherisk Program of Toronto, Canada , found that physicians are not following the FDA’s new guidelines. In his article, Scary Science: Ondansetron Safety in Pregnancy, Koren states, “…counseling of women who receive ondansetron for morning sickness reveals that these FDA precautions are not being followed.”


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