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U.S. Department of Health and Human Services

Safety

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Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets March 2009

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

 

Sections Modified

Summary of Changes to Contraindications and Warnings

BOXED WARNING

CONTRAINDICATIONS

WARNINGS

  • Hypersensitivity Reaction

PRECAUTIONS

  • Myocardial Infarction

MEDICATION GUIDE

  • Observed During Clinical Practice
    • Cardiovascular: Myocardial infarction.

BOXED WARNING

  • Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitvity reaction to abacavir...

CONTRAINDICATIONS

  • Trizivir tablets are contraindicated in patients with previously demonstrated hypersensitivity to abacavir or to any other component of the product...
  • Never restart Trizivir or any other abacavir-containing product...

WARNINGS

  • Hypersensitivity Reaction
    • Serious and sometimes fatal hypersensitivity reactions have
      been associated with Trizivir...
    • HLA-B*5701-negative patients may develop a hypersensitivity reaction to abacavir...

 

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