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Zofran Recall

Zofran Recall

The FDA has recalled Zofran in 32-mg intravenous doses due to concern about abnormal heart rhythm disorders, including QT interval prolongation and Torsades de Pointes.

What You Can Do & How a Zofran Lawsuit Can Help

The Schmidt Firm, PLLC is currently accepting Zofran induced injury cases in all 50 states. If you or somebody you know had a baby with a birth defect after taking Zofran during pregnancy, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Zofran Recall

In December 2012, recall was issued for 32-mg intravenous (IV) Zofran and the U.S. Food and Drug Administration (FDA) has issued more warnings about the risk of severe, life-threatening heart rhythm disorders.

The FDA has been investigating the link between Zofran and heart problems since September 2011. They asked the manufacturer of Zofran, GlaxoSmithKline (GSK), to conduct new safety studies.

Unfortunately, those studies indicated that Zofran could prolong a patient’s QT interval. In June 2012, the FDA issued a Safety Communication and warned:

“Specifically, at the highest tested single intravenous dose of 32 mg, the maximum mean difference in QTcF from placebo after baseline-correction was 20 msec. At the lower tested single intravenous dose of 8 mg, the maximum mean difference in QTcF from placebo after baseline-correction was 6 msec.”

QT Interval Prolongation

QT interval prolongation is a heart rhythm disorder involving an abnormally long “re-charging” period between heartbeats. The condition is a side effect of many medications.

In very serious cases, it can lead to a life-threatening condition known as Torsades de Pointes, which literally translates to “twisting of the points.” This is a severe heart rhythm disorder that can cause sudden death.

Risk-factors for QT prolongation include:

  • Electrolyte imbalances (hypokalemia, hypomagnesemia)
  • Congestive heart failure
  • Bradyarrhythmia
  • Other medications that can cause QT prolongation

Do I have a Zofran Lawsuit?

The Schmidt Firm, PLLC is currently accepting Zofran induced injury cases in all 50 states. If you or somebody you know had a baby with a birth defect after taking Zofran during pregnancy, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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