Label Changes for:
Elmiron (pentosan polysulfate sodium) Capsules
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.|
- Drug Interactions
- Pregnancy Exposure Registry
- Nursing Mothers
- Post Marketing Experience
- .........SJS, TEN, cholestatic jaundice, abnormal LFTs....