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U.S. Department of Health and Human Services

Safety

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Heparin Sodium in 0.9% Sodium Chloride Injection February 2009

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. Read about the new physician labeling format.


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

 

The latest label is not available on this site