Label Changes for:

Fludara (fludarabine phosphate), 50 milligrams, for intravenous injection

February 2009

Changes have been made to the BOXED WARNING, 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

BOXED WARNING

WARNINGS

  • Pregnancy Category D

PRECAUTIONS

  • Nursing Mothers

BOXED WARNING

  • ....including coma, seizures, agitation and confusion,.....

WARNINGS

  • ....Similar severe central nervous system toxicity, including coma,......
  • Pregnancy Category D
    • on its mechanism of action, fludarabine phosphate can cause fetal harm ...
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