Zofran | One Call, That's All

Zofran’s (also known as Ondansetron) Function

Typically prescribed for patients after receiving cancer treatments or surgeries to prevent nausea and vomiting. It works by blocking the actions of chemicals (Serotonin) in the body that can trigger nausea and vomiting.

Zofran has been used off-label to treat pregnant women for morning sickness. No drugs are currently approved for treating morning sickness in the United States, although doctors are free to prescribe whatever they think is best

The impacts of Zofran on prenatal development is currently under investigation as recent studies have linked Zofran to higher risks of delivering children with craniofacial defects, major congenital heart defects, and kidney malformations.

In 2014, the drug was moved to Category B on the FDA’s Pregnancy Drug List, which means that the risks to a fetus are not largely known due to a lack of human testing.

Zofran's (also known as Ondansetron) Function

Side Effects

In 2012, the FDA issued a black box warning, stating Ondansetron may increase the risk of developing prolongation of the QT interval of the electrocardiogram, which can lead to an abnormal and potentially fatal heart rhythm. The company’s label warns against several risks associated with Zofran:

Confusion
dizziness
fast heartbeat
fever
headache
shortness of breath
weakness
Decrease in the frequency of urination
decrease in the urine volume
difficulty with passing urine (dribbling)
painful urination

Studies Reported

In January 2012, researchers found that children exposed to Ondansetron during their first trimester of pregnancy were twice as likely to develop cleft palates. There findings warrant further investigation into an association between Ondansetron and an increased risk of birth defects, when the medication is taken for nausea and vomiting during pregnancy.

Another study conducted in Denmark, included all women giving birth in Denmark between 1997 and 2010. The group looked for a significant difference in birth defects between children that had been exposed to Ondansetron during their first trimester, and those that were not. They found an increase in the prevalence of major congenital heart defects in children whose mother’s received a prescription for Ondansetron in their first trimester.

Prior to the aforementioned study in Denmark, a study was published in the New England Journal of Medicine, which found that Ondansetron was not significantly associated with numerous risks to prenatal development. Once again, this study was conducted in Denmark, and the contradictory results are representative of the need for further information on the associated risks of Ondansetron.

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