Zofran Heart Rhythm Side Effects Lawsuits
Zofran Side Effects Injury 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
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Regarding Zofran?
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Zofran News & Lawsuits
GlaxoSmithKline Zofran’s Warning Label. Zofran Anti-nausea Medication Was Approved by The U.S. Food and Drug Administration (FDA) specifically for the treatment of vomiting and nausea as a side effect from chemotherapy, radiation, and for surgery patients after taking post-operative medications. GlaxoSmithKline (GSK), makers of Zofran (ondansetron), however, marketed the drug for nausea in pregnant women even… Read more...
Zofran is manufactured by GlaxoSmithKline or GSK as an anti-nausea medication. The US Food and Drug Administration approved the drug in 1991 for patients undergoing chemotherapy, radiation therapy, and for post-operative nausea. Despite the FDA only approving Zofran as anti-nausea medication under those specifications, the generic version of the drug, Ondansetron, has been prescribed to… Read more...
Zofran Lawsuits Transfered to U.S District Court. Zofran Lawsuits From Missisipi and Texas Transfered to U.S District Court. 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.… Read more... Zofran Lawsuit From Missisipi and Texas. 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… Read more...
Zofran Approved for Cancer Treatments But Not In Pregnancy Related Nausea. GlaxoSmithKline's (GSK) anti-nausea medication, Zofran (ondansetron), is the focus of a new lawsuit. Zofran is approved for use in post-operative surgery patients and patients undergoing certain cancer treatments to combat nausea. Although Zofran is not approved to treat pregnancy-related nausea and vomiting, approximately one million… Read more...
The Blame of Zofran. 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… Read more...
Zofran Caused Birth Defects? Thelitigation 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 ofbirth defects associated with Zofran. GSK has also been accused of marketing Zofran off-label for morning sickness, even though the… Read more...
On Going Case Against Zofran Birth Defect. 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… Read more...
Xarelto's Manufacturers Versus Plaintiffs. Novartis Pharmaceuticals has been named alongside GlaxoSmithKline in litigation over the anti-nausea medication Zofran. Some 250 lawsuits were consolidated in the U.S. District Court of Massachusetts alleging the drug makers illegally promoted Zofran off-label for morning sickness, leading to birth defects. On May 31, 2016 a Master Long Form Complaint named Novartis,… Read more...
Zofran Birth Defect Litigation. U.S. District Judge F. Dennis Saylor IV has denied GlaxoSmithKline's motion to dismiss all claims in multidistrict litigation alleging that the company's off-label promotion of its anti-nausea drug Zofran (ondansetron) for morning sickness led to birth defects. Judge Saylor denied the pharmaceutical company's motion to dismiss, saying that he was… Read more...
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