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U.S. Department of Health and Human Services

Safety

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Clozaril (clozapine) Tablets June 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2008

 

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.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS

  • Tardive Dyskinesia

ADVERSE REACTIONS

  • Extrapyramidal Symptoms
    • Dystonia

WARNINGS

Tardive Dyskinesia

...There are several reasons for predicting that Clozaril may be different from other antipsychotic drugs in its potential for inducing tardive dyskinesia, including the preclinical finding that it has a relatively weak dopamine-blocking effect and the clinical finding of a low incidence of certain acute extrapyramidal symptoms, e.g., dystonia...

 

Label approved 06/26/2008 is not available on Drugs@FDA

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