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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)
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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