April 2013 Safety Labeling Changes

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The MedWatch April 2013 Safety Labeling Changes posting includes 48 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

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

 http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm348021.htm

The following drugs had modifications to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections:

Actonel (Risedronate Sodium) 
Actonel with Calcium (Risedronate Sodium with Calcium Carbonate)
Actemra (Tocilizumab) 
Ambien (Zolpidem Tartrate)
Ambien CR (Zolpidem Tartrate) 
Amrix (Cyclobenzaprine Hydrochloride)  
Atacand (Candesartan Cilexetil)
Atacand HCT (Candesartan Cilexetil/Hydrodchlorothiazide)
Atelvia (Risedronate Sodium) 
Atripla (Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate)    
Binosto (Alendronate Sodium) 
Boniva (Ibandronate Sodium)
Coartem (Artemether/Lumefantrine)  
Cogentin (Benztropine Mesylate) 
Didronel (Itidronate Disodium)
Dificid (Fidaxomicin)
Edluar (Zolpidem Tartrate)   
Emtriva (Emtricitabine) 
Flexeril (Cyclobenzaprine Hydrochloride)
Fosamax (Alendronate Sodium)
Fosamax Plus D (Alendronate Sodium/Cholecalciferol)        
Incivek (Telaprevir)
Jalyn (Dutasteride and Tamsulosin Hydrochloride)    
Juxtapid (Lomitapide)   
Nulojix (Belatacept)   
Pradaxa (Dabigatran Etexilate Mesylate)
Qualaquin (Quinine Sulfate)     
Rebif (Interferon Beta-1a)
Samsca (Tolvaptan)
Seroquel (Quetiapine Fumarate)     
Seroquel XR (Quetiapine fumarate)    
Simponi (Golimumab)    
Supprelin LA (Histrelin Acetate)
Victozo (Liraglutide [rDNA orgin])
Viread (Tenofovir Disoprixil Fumarate)

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