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FDA Pulls Zofran 32 mg due to Potential For Serious Cardiac Risks

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Washington, DC: The Food and Drug Administration (FDA) is pulling the 32 mg, single intravenous (IV) dose of the anti-nausea drug Zofran (ondansetron hydrochloride) from the US market because of the potential for serious cardiac risks.

The 32 mg, single IV dose of Zofran had been used to prevent chemotherapy-induced nausea and vomiting. A previous Drug Safety Communication (DSC), issued on June 29, 2012, communicated that the 32 mg, single IV dose should be avoided due to the risk of a specific type of irregular heart rhythm called QT interval prolongation, which can lead to Torsades de Pointes, an abnormal, potentially fatal heart rhythm. These drugs are sold pre-mixed in solutions of either dextrose or sodium chloride in plastic containers.

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ZOFRAN CARDIAC RISK LEGAL ARTICLES AND INTERVIEWS

Families Ask GSK to Hand Over Zofran Data
Families Ask GSK to Hand Over Zofran Data
February 27, 2018
Washington, DC: Families of patients who allegedly suffered birth defects while taking GlaxoSmithKline’s (GSK) anti-nausea drug Zofran, and who are suing the drug maker in multi-district litigating (MDL) are asking that the drug maker hand over data stored in a drug safety database called “Argus.&rdquo READ MORE

Zofran Litigation Making Progress
Zofran Litigation Making Progress
September 12, 2016
Houston, TX: Another Zofran lawsuit filed by parents in Texas joins more than 300 suits filed nationwide against the manufacturer. Most all federal cases consolidated into a multidistrict litigation in Massachusetts are making progress and a first trial date is expected soon READ MORE

Zofran Complaints Mounting with Increased Awareness of Birth Defects
Zofran Complaints Mounting with Increased Awareness of Birth Defects
August 10, 2016
Birmingham, AL: Many women who took Zofran during their pregnancy had idea that it is prescribed “off-label”, meaning it wasn’t approved by the FDA to treat morning sickness READ MORE
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