Label Changes for:

Heparin Sodium in 0.9% Sodium Chloride Injection

February 2009

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) -- February 2009

 

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

  • Fatal Medication Errors
  • Thrombocytopenia
  • Heparin-induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis
  • Delayed Onset of HIT and HITT
  • Use in Neonates

PRECAUTIONS

  • General
    • HIT and HITT

ADVERSE REACTIONS

  • Thrombocytopenia, Heparin-induced Thrombocytopenia (HIT), Heparin-induced Thrombocytopenia and Thrombosis (HITT) and Delayed Onset of HIT and HITT

WARNINGS

  • Fatal Medication Errors
    • Heparin is supplied in a wide range of strengths. Fatal hemorrhages have occurred in infants and pediatric patients ....
  • Thrombocytopenia
    • ...of up to 30%. Platelet counts
      should be obtained at baseline....
  • Heparin-induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis
    • new section
  • Delayed Onset of HIT and HITT
    • new section
  • Use in Neonates
    • new section

 

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