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U.S. Department of Health and Human Services

Safety

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Resources for You

Lexiscan (regadenoson) Injection March 2009

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

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

  • (6.1) Clinical Trials Experience
  • (6.2) Post Marketing Experience
    • Cardiovascular
    • Gastrointestinal
    • Musculoskeletal
    • Respiratory

WARNINGS AND PRECAUTIONS

  • Sinoatrial and Atrioventricular Nodal Block
    • In postmarketing experience, third degree heart block and asystole within minutes of Lexiscan administration have occurred
  • Hypotension
    • In postmarketing experience, syncope and transient ischemic attacks have been observed