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Label Changes for:

Zofran (ondansetron hydrochloride) Injection

November 2012

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

November 2012

WARNINGS AND PRECAUTIONS

QT Prolongation
  • Ondansetron prolongs the QT interval in a dose-dependent

 

 

September 2011

WARNINGS

Electrocardiographic Changes
  • Information regarding post-marketing case reports of Torsade de Pointes
  • Recommendation to avoid use in patients with known congenital long QT syndrome
  • ECG monitoring recommendation in patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation
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