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Reference Desk January 2013

FDA 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)

    Source: FDA


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