August 2012 Safety Labeling Changes

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The MedWatch August 2012 Safety Labeling Changes posting includes 53 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/ucm315860.htm

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

Aplenzin (Bupropion Hydrobromide)
Atrovent HFA (Ipratropium Bromide HFA)
Avelox (Moxifloxacin Hydrochloride)
Bactrim (Sulfamethoxazole and Trimethoprim)
Capoten (Captopril)
Coartem (Artemether/Lumefantrine)
Complera (Emtricitabine, Rilpivirine, Tenofovir
Diovan (Valsartan)Bactrim DS (Sulfamethoxazole and Trimethoprim)
Diovan HCT (Valsartan/Hydrochlorothiazide)
Disoproxil Fumarate)
Edurant (Rilpivirine)
Fuzeon (Enfuvirtide)
Intelence (Etravirine)
Invega Sustenna (Paliperidone Palmitrate)
Isentress (Raltegravir)
Lamictal (Lamotrigine) and Lamictal XR (Lamotrigine)
Leustatin (Cladribine)
Lovaza (Omega-3-Acid Ethyl Esters)
Lucentis (Ranibizumab)
Mirapex (Pramipexole Dihydrochloride) and Mirapex ER (Pramipexole Dihydrochloride)
Moviprep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid)
Neoral Soft Gelatin (Cyclosporine)
Neoral oral Solution (Cyclosporine)
Nexavar (Sorafenib)
Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)
Ortho Evra (Norelgestromin/Ethinyl Estradiol)
Oxaliplatin (Oxaliplatin)
Revatio (Sildenafil)
Sanctura XR (Trospium Chloride)
Sandimmune (Cyclosporine, USP)
Selzentry (Maraviroc)
Strattera (Atomoxetine Hydrochloride)
Sustiva (Efavirenz)
Toviaz (Fesoterodine Fumarate)
Tradjenta (Linagliptin)
Trobicin (Spectinomycin)
Ultane and Ultane NovaPlus (Sevoflurane)
Vectibix (Panitumumab)
Viread (Tenofovir Disoproxil Fumarate

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