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U.S. Department of Health and Human Services

Safety

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Ultane and Ultane NovaPlus (Sevoflurane) Volatile Liquid for Inhalation

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

 

March 2014

Summary View

WARNINGS

  • Reports of QT prolongation, associated with torsade de pointes (in exceptional cases, fatal), have been received. Caution should be exercised when administering sevoflurane to susceptible patients (e.g. patients with congenital Long QT Syndrome or patients taking drugs that can prolong the QT interval).

 

August 2012

Summary View

WARNINGS

  • e.g., patients with congenital Long QT Syndrome or patients taking drugs that can prolong the QT interval).