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U.S. Department of Health and Human Services

Safety

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Pexeva (paroxetine mesylate) tablet

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2009, and April 2011

 

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.

 

April 2011

Summary View  

 

PRECAUTIONS

Tamoxifen
  • ...tamoxifen drug interaction...

 

MEDICATION GUIDE

Before starting Pexeva, tell your healthcare provider if you:
  • ...tamoxifen... added

 

January 2009

Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS

  • Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions

WARNINGS

  • The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including Pexeva treatment, but particularly with concomitant use of serotonergic drugs (including triptans) with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists.....