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U.S. Department of Health and Human Services

Safety

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Lybrel (90 mcg levonorgestrel and 20 mcg ethinyl estradiol) Tablets September 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 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. Read about the new physician labeling format.


Summary View

 

Sections Modified

ADVERSE REACTIONS

  • Focal nodular hyperplasia (added)

BRIEF SUMMARY PATIENT PACKAGE INSERT

  • BEFORE YOU START TAKING LYBREL

DETAILED PATIENT LABELING

  • BEFORE YOU START TAKING LYBREL