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U.S. Department of Health and Human Services

Safety

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Treanda (bendamustine hydrochloride) for Injection, 100 mg

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

  • Suicidal behavior and Ideation
  • Usage in Pregnancy

 

PRECAUTIONS

  • Information for Patients

WARNINGS and PRECAUTIONS

  • Skin Reactions
    • A number of skin reactions have been reported in clinical trials and post-marketing safety reports. These events have included rash, toxic skin
      reactions and bullous exanthema. Some events occurred when Treanda was given in combination...
    • ...one case of toxic epidermal necrolysis (TEN) occurred...Cases of Stevens-Johnson syndrome (SJS) and TEN, some fatal, have been reported...