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U.S. Department of Health and Human Services

Safety

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Byetta (exenatide) injection


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

  • General
    • Postmarketing cases of acute pancreatitis have been reported...
  • Information for Patients
    • Patients should be informed that persistent severe abdominal pain, which may be accompanied by vomiting, is the hallmark symptom of acute pancreatitis...

PATIENT PACKAGE INSERT

  • What are the possible side effects of Byetta?
    • ...Talk to your healthcare provider if you experience the following severe and persistent symptoms, alone or in combination, because they could be signs of a serious medical condition: abdominal pain or vomiting.