Label Changes for:

Arixtra (fondaparinux sodium) injection

September 2013

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

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

 

 

September 2013

4 CONTRAINDICATIONS

  • History of serious hypersensitivity reaction (e.g., angioedema, anaphylactoid/anaphylactic reactions) to ARIXTRA

6 ADVERSE REACTIONS

6.5 Postmarketing Experience
  • the occurrence of serious allergic reactions (including angioedema and anaphylactoid/anaphylactic reactions) 

 

March 2010

USE IN SPECIFIC POPULATIONS

Pediatric Use
  • Safety and effectiveness of Arixtra in pediatric patients have not been established. Because risk for bleeding during treatment with Arixtra is increased in adults who weigh <50 kg, bleeding may be a particular safety concern for use of Arixtra in the pediatric population.

 

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