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U.S. Department of Health and Human Services

Safety

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Clozaril (clozapine) Tablets

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

 

March 2013

Summary View

WARNINGS

Metabolic Changes
  • Atypical antipsychotic drugs, including CLOZARIL have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes may include hyperglycemia, dyslipidemia, and body weight gain. While atypical antipsychotic drugs may produce some metabolic changes, each drug in the class has its own specific risk profile

ADVERSE REACTIONS

Postmarketing Experience
  • Hepatobiliary System: hepatotoxicity, hepatic steatosis, hepatic necrosis, hepatic fibrosis, hepatic cirrhosis, liver injury (hepatic, cholestatic, and mixed), and liver failure
  • Urogenital System - Renal failure 

 

October 2011 

Summary View

 

WARNINGS

QT Interval Prolongation
  • section added

 

PRECAUTIONS

Drug Interactions and Pharmacodynamic-Related Interactions
  • ... QT prolongation
Pharmacokinetic-Related Interactions
  • ... QT prolongation

 

DRUG INTERACTIONS

Post-marketing Clinical Experience

Cardiovascular system

  • ... QT prolongation

 

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.
 
November 2008

 

Summary View

 

Sections Modified

PRECAUTIONS

  • Drug Interactions
    • Pharmacokinetic-Related Interactions
      • Concomitant administration of drugs known to inhibit the activity of cytochrome P450 isozymes may increase the plasma levels of clozapine...
        • citalopram (added to list of drugs)

ADVERSE REACTIONS

  • Other Events Observed During the
    Premarketing Evaluation of Clozaril (clozapine)
    • Metabolic and Nutritional Disorders (new subsection)
      • hypercholesterolemia and hypertriglyceridemia

 

For current prescribing information, contact Novartis Pharmaceuticals at 1-888-669-6682.

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