Label Changes for:

Cancidas (caspofungin acetate) for Injection

October 2010

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

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

 

October 2010

 

 

ADVERSE REACTIONS

  • angioedema

 

January 2010 

 

WARNINGS AND PRECAUTIONS

Hepatic effects
  • ...in healthy volunteers and in adult and pediatric patients...In some adult and pediatric patients...

USE IN SPECIFIC POPULATION

Pediatric Use
  • Postmarketing hepatobiliary adverse events have been reported in pediatric patients with serious underlying medical conditions
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