Label Changes for:
Zofran (ondansetron hydrochloride) tablets, oral solution, and orally disintegrating tablets
Changes have been made to the WARNINGS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2011
- 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