Label Changes for:

Elmiron (pentosan polysulfate sodium) Capsules

December 2008

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- December 2008

 

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

PRECAUTIONS

  • Drug Interactions
  • Pregnancy Exposure Registry
  • Nursing Mothers

ADVERSE REACTIONS

  • Post Marketing Experience
    • .........SJS, TEN, cholestatic jaundice, abnormal LFTs....
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