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U.S. Department of Health and Human Services

Safety

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Resources for You

Eloxatin (oxaliplatin) powder for solution for intravenous use 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

ADVERSE REACTIONS

  • Postmarketing Experience
    • after other interstitial lung diseases added "sometimes fatal"
    • transient vision loss (reversible following therapy discontinuation)

Information for Patients

  • Updated ... vision abnormalities that may affect patients’ ability to drive and
    use machines.