Label Changes for:

Fazaclo (clozapine) orally disintegrating tablets

September 2010

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2010

 

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
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