MedWatch December 2012 Safety Labeling Changes


 The MedWatch December 2012 Safety Labeling Changes posting includes 42 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.


The “Summary Page” provides a listing of drug names and safety labeling sections revised:

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS and/or WARNINGS sections:

  • Altabax (Retapamulin)
  • Antara (Fenofibric Acid)
  • Celexa (Citalopram Hydrobromide)   
  • Chantix (Varenicline)
  • Edurant (Rilpivirine)    
  • Effexor (Venlafaxine Hydrochloride)
  • Effexor XR (Venlafaxine Hydrochloride)
  • Fibricor (Fenofibric Acid) 
  • Horizant (Gabapentin Enacarbil)    
  • Incivek (Telaprevir) 
  • Lexapro ( Escitalopram Oxalate)
  • Omeprazole Sodium Bicarbonate and Magnesium Hydroxide
  • Omontys (Peginesatide)    
  • Paxil (Paroxetine Hydrochloride)
  • Pexeva (Paroxetine Mesylate)
  • Pradaxa (Dabigatran Etexilate)
  • Pristiq (Desvenlafaxine)
  • Sabril (Vigabatrin)  
  • Surmontil (Trimipramine Maleate)   
  • Tamiflu (Oseltamivir Phosphate)
  • Venlafaxine  
  • Viibryd (Vilazodone HCL)
  • Xyrem (Sodium Oxybate)
  • Zoloft (Sertraline Hydrochloride)      
  • Zytiga (Abiraterone Acetate)
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