Zofran RecallFollowing years of concern about heart rhythm side effects, the FDA has recalled the highest dose of intravenous Zofran due to the potential for sudden cardiac death.

Need a Texas Zofran Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one had a baby with a birth defect after taking Zofran during pregnancy, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.

Zofran Recall

December 4, 2012 — The FDA has recalled 32-mg intravenous (IV) injections of Zofran.

The agency is concerned about the risk of a heart rhythm disorder known at QT interval prolongation, which can lead to a life-threatening condition known as Torsades de Pointes.

What is the problem?

The FDA has been investigating heart rhythm side effects of Zofran since September 2011, when they issued a Safety Communication.

At the same time, the FDA ordered GlaxoSmithKline (GSK), the manufacturer of Zofran, to conduct a thorough safety study to assess the risk of heart rhythm disorders. The results of the study were published in June 2012 and suggested a potential risk, resulting in another warning and removal of the 32-mg intravenous dose.

QT Interval Prolongation

The QT interval is the time it takes for the electrical current in the heart to “re-charge” so the heart can beat again. A long interval is a risk-factor for Torsades de Pointes (“twisting of the points”), which is an extremely severe heart rhythm disorder that can cause sudden death.

After GSK published a study linking Zofran and QT interval prolongation, the FDA 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.”

Risk-Factors

Before this study was published, the label on Zofran already contained information about QT prolongation. In 2012, the label was updated to include more warnings about the side effect in patients with certain risk-factors, including:

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

Need a Zofran Lawyer in Texas?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Zofran lawyers for a free lawsuit review.