Zofran is a drug that has been commonly used by medical professionals to prevent nausea and vomiting in patients undergoing chemotherapy, surgery, and radiation therapy. It has also been prescribed to pregnant women to help prevent “morning sickness,” the nausea and vomiting frequently suffered during pregnancy.
Although the FDA approved this drug for use by the public, years later it issued a safety announcement stating that ondansetron (Zofran) may affect “QT interval prolongation” – the heart’s electrical activity – causing a predisposition to abnormal and potentially fatal heart rhythms in a condition known as “Torsades de Pointes.”
If you or your loved one has suffered abnormal heart rhythms or other health complications after taking Zofran, contact a knowledgeable product liability lawyer as soon as possible. At Farah & Farah, our practice is devoted to holding pharmaceutical companies responsible for the damage they cause and pursuing justice and compensation for our clients. We represent people nationwide who have been injured by Zofran.
FDA Instructions to Doctors Regarding Zofran
The FDA issued its first warning about this drug in September of 2011, updated its information in June 2012, and then recalled the 32 mg single intravenous dosage in December 2012. In the initial warning it issued, the FDA instructed physicians that:
- ECG changes had been seen with patients on Zofran, including QT interval prolongation.
- Torsades de Pointes had been reported in patients using this drug.
- ECG monitoring was recommended for patients on this drug with electrolyte abnormalities, congestive heart failure, bradyarrhythmia (slow heart rate), and patients taking other medications that prolong the QT interval.
- Patients on Zofran should be advised to get medical help immediately if they experience symptoms of abnormal heart rhythm.
- Physicians should report any adverse events following the use of Zofran to the FDA MedWatch program.
Symptoms to Be Aware of With Zofran
In its drug safety warning about Zofran, the FDA also issued information to patients using the drug. It warned that their doctors may order electrocardiograms occasionally, to monitor their heart rhythms and heart rate. It advised patients to seek immediate medical care if they experienced any of these symptoms while taking Zofran:
- Irregular heartbeat
- Shortness of breath
- According to the Mayo Clinic, patients should contact their doctor immediately if any of the above or any of the following symptoms occur:
- Fast heartbeat
The FDA states that those who are at particular risk of developing potentially fatal abnormal heart rhythms from taking Zofran include patients with underlying heart conditions, patients with low levels of magnesium and potassium in their blood, and patients who are taking other medications that could cause QT prolongation.
Maternal Heart Rhythm Risks with Zofran during Pregnancy
The National Center for Biotechnology Information (NCBI) published an abstract on the safety of using ondansetron during pregnancy for morning sickness. Researchers found that many women have electrolyte imbalances during pregnancy, and because of the risks of QT prolongation and Torsades de Pointes associated with using Zofran, other drugs with better safety records should be tried first to control nausea and vomiting during pregnancy.
Zofran Passes Through To the Fetus When Taken During Pregnancy
Although it has not been approved by the FDA for use during pregnancy, Zofran has been frequently prescribed for the nausea and vomiting of “morning sickness,” which typically occurs during the first pregnancy trimester. In 2013, the National Center for Biotechnology Information (NCBI) published a study conducted by the American Society for Clinical Pharmacology and Therapeutics in which researchers found that Zofran passes quickly through the placenta to the fetus when taken during pregnancy, with a longer elimination half-life in the fetus than in the mother.
Stated differently, when the mother takes Zofran as prescribed during pregnancy, the drug passes through to the fetus in significant amounts and remains active longer for the fetus than it does for the mother. If Zofran can cause abnormal and potentially fatal heart rhythms in adults, what is the potential for harm to the developing fetus? Studies have linked Zofran taken during the first trimester of pregnancy to birth defects in infants, including craniofacial defects, kidney defects, and heart defects.
Contact Us about Adverse Effects from Using Zofran
If you or your loved one has been harmed by taking Zofran, you may be entitled to recover compensation for the damages you have suffered. Contact Farah & Farah at (800) 533-3555 right away for a free consultation. Our Zofran heart defect lawyers are knowledgeable and tenacious. We will fight relentlessly for full financial compensation on your behalf.