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U.S. Department of Health and Human Services

Safety

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Fazaclo (clozapine) orally disintegrating tablet

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

 

January 2012

Summary View

WARNINGS

QT Interval Prolongation
  • QT prolongation is associated with an increased risk for life-threatening ventricular arrhythmias including Torsades de Pointes. Treatment with FazaClo (clozapine, USP) has been associated with QT prolongation as well as ventricular arrthymia, Torsades de Pointes, cardiac arrest, and sudden death. Caution should be exercised when .....

PRECAUTIONS

Drug Interactions and Pharmacodynamic-Related Interactions:
QT prolongation: 
  • Treatment with FazaClo® (clozapine, USP) , has been associated with QT interval prolongation and fatal arrhythmia......
Pharmacokinetic-related Interactions
QT Prolongation: 
  • Use caution when prescribing FazaClo......

ADVERSE REACTIONS

Postmarketing Clinical Experience:
Cardiovascular System
  • Ventricular tachycardia, cardiac arrest, QT prolongation, and Torsades de Pointes.

 

September 2010

Summary View

 

PRECAUTIONS

Cerebrovascular adverse events
  • An increased risk of cerebrovascular adverse events has been seen in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations. Clozaril should be used with caution in patients with risk factors for stroke.

ADVERSE REACTIONS

Postmarketing Clinical Experience
  • Central Nervous System: obsessive compulsive symptoms
  • Metabolic and Nutritional Disorders: new onset diabetes
  • Respiratory System: pneumonia and lower respiratory tract infection which may be fatal