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Zofran (ondansetron) Heart Rhythm Side Effects Lawsuits

Zofran® (ondansetron) Heart Rhythm Side Effects Lawsuits

Zofran  & Abnormal Heart Rhythm Complications

Zofran® (ondansetron) Heart Rhythm Side Effects Lawsuits

Our firm is currently investigating potential lawsuits on behalf of Zofran users who experienced heart rhythm complications.
Research indicates that Zofran, an anti-nausea medication given to patients undergoing chemotherapy, may lead to an abnormal heart rhythm. This potential side effect may lead to serious and potentially fatal cardiac events, such as Torsade de Pointes. These risks have been addressed by the regulators in the United States, and more in recently in Canada.

Zofran Overview

Zofran, known generically as ondansetron, was approved in 1992 to prevent nausea and vomiting in patients undergoing chemotherapy, radiation therapy and surgery. It works by inhibiting serotonin, a natural substance that causes vomiting. Zofran is manufactured by GlaxoSmithKline and is part of the 5HT3 drug class. This medication however, has raised safety concerns due to its potential impact on the heart.

In September 2011, the U.S. Food and Drug Administration (FDA) updated the label of Zofran to address its risks on cardiac health. The agency warned that the medication may lead to QT prolongation, which may indicate an abnormal or fatal heart rhythm, such as Torsade de Pointes. Long QT syndrome and Torsade de Pointes are detected using an electrocardiogram (ECG).

Health Canada Warning and Label Changes

In October 2012, the safety label on Zofran was updated in Canada; Health Canada and GlaxoSmithKline collaboratively warned patients that Zofran is associated with abnormal electrical activity in the heart when used in high doses.
The notification cited a new study showing that Zofran may interrupt the QT interval and announced several changes in the medication’s safety information changes, including the following:

  • Zofran can impact the electrical activity in the heart at high doses, leading to dizziness; rapid, pounding, or irregular heartbeat; fainting; or death
  • Zofran should not be administered in 32 mg intravenous doses. The new maximum IV dose is 16 mg in adults
  • Patients with QT prolongation should not take Zofran
  • Patients with heart problems or taking any medications should speak with their doctor before taking Zofran
  • Patients who experience dizziness, abnormal heartbeat or fainting while taking Zofran should seek medical attention immediately

Zofran Side Effects

Zofran has been linked to an abnormal heart rhythm. Although conditions such as prolonged QT syndrome and Torsade de Pointes is usually diagnosed using an ECG, patients may experience physical signs of an irregular heartbeat, including:

  • Heart palpitations
  • Pounding or discomfort in the chest
  • Fainting, dizziness or light headedness
  • Shortness of breath
  • Weakness, fatigue

Legal Evaluation for Zofran Users Who Suffered
Cardiac Side Effects

If you or a loved one suffered QT prolongation, Torsades de Pointes or another cardiac complication after taking Zofran, our lawyers would like to speak to you. To learn about your legal rights and how our personal injury and product liability lawyers can help you, please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case with one of our experienced attorneys.



Zofran (ondansetron) Heart Rhythm Side Effects LawsuitsRSS Feed

New Zofran Lawsuits Moved to Multidistrict Litigation in Boston

Oct 21, 2016
Two additional Zofran lawsuits, with plaintiffs from Mississippi and Texas, have been transferred to Zofran MDL 2675 pending in U.S. District Court of Massachusetts, before Judge F. Dennis Saylor, where the litigation has been consolidated for pre-trial proceedings. There is now a total of 282 lawsuits against the multinational manufacturer of Zofran, GlaxoSmithKline, that have been consolidated in the Boston federal court. Zofran was initially approved by the U.S. Food and Drug Administration...

Zofran Caused Heart Defects, Facial Abnormalities

Aug 8, 2016
A recently filed lawsuit alleges that Zofran, an anti-nausea medication manufactured by GlaxoSmithKline (GSK), is to blame for a child's congenital abnormalities, including two cardiac defects and facial dysmorphia. The suit was filed on behalf of a woman who says that she was prescribed Zofran to treat morning sickness and migraines during her first trimester of pregnancy. In May 2007, her daughter was born with atrial and ventricular septal defects. These “hole in the heart”...

Parties in Zofran Litigation Disagree on Sequenced Discovery

Jul 29, 2016
The litigation over Zofran, GlaxoSmithKline's anti-nausea drug, continues to move forward with more than 200 plaintiffs alleging that Zofran caused birth defects. GlaxoSmithKine (GSK) is accused of failing to warn about the risk of birth defects associated with Zofran. GSK has also been accused of marketing Zofran off-label for morning sickness, even though the FDA only approved the drug to treat nausea in patients undergoing chemotherapy or surgery. According to court records, the two parties...

Families Have New Option for Entering Zofran Birth Defect Litigation

Jul 21, 2016
Bayer AG and Janssen Pharmaceuticals (a subdivision of Johnson & Johnson) are manufacturers of Xarelto, an anticoagulant that was embraced as a breakthrough in blood clot prevention. Xarelto has less dietary restrictions and blood monitoring than the established blood thinner Coumadin (warfarin). However, an alleged connection between an elevated risk for catastrophic hemorrhages and Xarelto has led to numerous lawsuits. The suits are now being lent possibly increased credibility through...

Families Now Preparing Individual Complaints in Zofran Birth Defect Litigation

Jul 11, 2016
As part of pretrial proceedings in the Zofran birth defect lawsuits against GlaxoSmithKline, families are now completing documents with individual details of their cases. More than 200 birth defects lawsuits have been consolidated in a multidistrict litigation in federal court in Massachusetts overseen by Judge F. Dennis Saylor, IV. The lawsuits allege that GlaxoSmithKline's anti-nausea drug Zofran caused birth defects in the children of mothers who took the drug during pregnancy. Both sides...

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