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Zofran FDA Warnings

Anti-nausea drug ondansetron (Zofran) was developed by GlaxoSmithKline in the 1980s, patented in 1987, and approved by the U.S. Food and Drug Administration (FDA) in 1991. The first generic versions of Zofran were approved by the FDA in 2006. Since that time, the FDA has issued several warnings and contraindications about the safety of this drug.

It is important to note that although Zofran has been FDA-approved to control nausea and vomiting in patients undergoing chemotherapy and radiation therapy, and for post-surgical nausea and vomiting, it was never FDA approved to treat pregnant women. Nevertheless, doctors frequently prescribe this drug to pregnant women for morning sickness “off-label” (without FDA approval for that purpose).

As stated in a study published by the American Journal of Obstetrics & Gynecology, in spite of FDA warnings about heart rhythm issues, as well as unresolved questions about fetal safety, the number of monthly prescriptions of Zofran for pregnant women increased from 50,000 in 2008 to 110,000 in 2013. In addition to FDA warnings, several recent studies have linked this drug to birth defects.

If you or someone you love has suffered harm after being prescribed Zofran, contact our drug side effect attorney as soon as possible. You may be entitled to file a claim for compensation. At Farah & Farah, we are investigating cases nationwide for people who have been injured by this drug, including parents of infants who were born with birth defects when the mother had been prescribed Zofran during pregnancy.

Zofran Warnings Issued by FDA

Zofran is a 5-HT3 receptor antagonist that works by partially blocking the action of serotonin, a key chemical in the brain involved in the body’s nausea response and many other body functions. Beginning in 2011, FDA has issued a number of safety communications about this drug, including:

  • 9-15-2011: Abnormal heart rhythms may be associated with the use of Zofran. FDA warns that abnormal changes in the electrical activity of the heart possibly associated with Zofran could result in potentially fatal abnormal heart rhythms. In its safety announcement, FDA stated that patients at particular risk for this dangerous drug side effect were those with underlying heart conditions, those predisposed to low blood levels of magnesium and potassium, and those taking other medications that could cause QT interval prolongation (changes in the electrical activity of the heart).
  • 9-16-2011: Drug safety podcast for medical professionals about abnormal heart rhythms that may be associated with Zofran. This presentation advises physicians that ECG changes, including QT interval prolongation, have been seen in patients on Zofran and that Torsades de Pointes (abnormal heart rhythms, potentially fatal) have been reported in patients on this drug.
  • 6-29-2012: New information about QT prolongation with Zofran. Preliminary results of a clinical study suggest that a 32 mg single intravenous dose of Zofran may affect the heart’s electrical activity, predisposing the patient to abnormal and potentially fatal heart rhythm. The announcement stated that GlaxoSmithKline was updating the Zofran drug label to remove the 32 mg intravenous dosage while stating that recommended lower dosages could be used for adults and children with nausea and vomiting induced by chemotherapy.
  • 12-4-2012: Announcement of the recall of the 32 mg intravenous dose of Zofran because of the potential for serious cardiac risks. FDA continues to recommend this drug for prevention of chemotherapy-induced nausea and vomiting, but not in any dosage exceeding 16 mg, because of the risk of QT interval prolongation.
  • March 2013: FDA Adverse Events Report identifying a potential safety issue with Zofran – the risk of serotonin syndrome. According to the Mayo Clinic, serotonin syndrome symptoms usually appear within several hours of taking a new drug or increasing a drug dosage. Symptoms of life-threatening severe serotonin syndrome include seizures, high fever, irregular heartbeat, and unconsciousness.
  • Dec 2013: FDA warning about a serious drug reaction – profound hypotension (low blood pressure) and loss of consciousness — when Zofran is taken with apomorphine, a drug used in the treatment of Parkinson’s disease. This safety warning, based on actual reports of this serious reaction, applies to all forms of Zofran – tablet, orally disintegrating tablet, injection, and oral solution.

If you or your loved one has been harmed by Zofran, our tenacious pharmaceutical litigation lawyers at Farah & Farah are prepared to fight relentlessly on your behalf, and are committed to helping victims pursue justice and full compensation. We believe that pharmaceutical companies should be held accountable for the harm to patients caused by dangerous drugs. Contact us today at (800) 533-3555 for a free case consultation to learn about your legal options, and how our firm can help.


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Who We Are

The pharmaceutical litigation attorneys at Farah & Farah go after negligent corporations that put unsuspecting consumers in harm's way. Pharmaceutical companies not only have a duty to manufacture drugs that are safe, but they also have the obligation to warn consumers regarding dangerous side effects that can be caused by these drugs.

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