Is Zofran Dangerous? Understanding Pregnancy & Zofran Injury

Zofran is a popular prescription medication that has been in use in the United States since 1992, when the FDA first approved it for treatment of cancer patients.

Specifically, Zofran helps to prevent nausea and vomiting caused by chemotherapy. But in recent years, it's become increasingly popular as an “off-label” treatment for pregnant women experiencing morning sickness.

A prescription is said to be “off-label” when a doctor instructs the patient to use it for treatments other than those for which the medication has been approved. While doctors generally have discretion to authorize off-label prescriptions, they have a duty to do so with great caution and care — and to inform the patient about the potential risks.

Unfortunately, in the case of Zofran, those risks may be profound. There is evidence indicating that the drug could cause serious injury in pregnant women who take the medication but who do not have cancer. Potential side effects include:

• Irregular heartbeat (arrhythmia)

• Rashes, itching, hives

• Dangerous swelling

• Shortness of breath

• Constipation

• Difficulty breathing or swallowing

• Dizziness or fainting

Additionally, the drug may cause birth defects in developing fetuses. The most common kinds of birth defect potentially related to Zofran injury include:

• Heart defects

• Musculoskeletal anomalies

• Mouth deformities

• Jaundice

In 2011, the FDA issued a warning about the risk of fatal cardiac arrhythmias in patients taking Zofran. Later, in 2013, the FDA put the drug on its official watch list, which means that the administration has identified a potential health risk and is investigating the danger further.

Meanwhile, here at Andrus Wagstaff PC, we are continuing to monitor the FDA's progress, as well as new claims by mothers and children who may have suffered injury or death after taking Zofran.