Eloxatin (oxaliplatin) concentrate 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.