Label Changes for:

Arixtra (fondaparinux sodium) Injection

October 2008

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 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. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS

  • Hemorrhage
  • Laboratory Testing
  • Thrombocytopenia

PRECAUTIONS

  • General
    • The needle guard of the prefilled syringe of Arixtra contains dry natural latex rubber that may cause allergic reactions in latex sensitive individuals.

ADVERSE REACTIONS

  • Postmarketing Experience (new subsection)

WARNINGS

Hemorrhage:

...Isolated cases of elevated aPTT temporally associated with bleeding events have been reported following administration of Arixtra (with or without concomitant administration of other anticoagulants) (see ADVERSE REACTIONS: Postmarketing Experience).

Laboratory Testing:

...In post-marketing experience, isolated occurrences of aPTT elevations have been reported following administration of -Arixtra (see PRECAUTIONS: Laboratory Tests and ADVERSE REACTIONS: Postmarketing Experience).

Thrombocytopenia:

...Isolated occurrences of thrombocytopenia with thrombosis that manifested similar to heparin induced thrombocytopenia have been reported with use of Arixtra in postmarketing experience (see ADVERSE REACTIONS: Postmarketing Experience)...

Label approved 10/17/2008 is not available on this site

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