Safety Information > August 2012

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Safety Information > August 2012




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

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information. Key to Label Section Acronyms:BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE
DRUG NAME SECTIONS MODIFIED (Click on drug name to go to detailed view) BW C W P AR PPI/MG Aplenzin (Bupropion Hydrobromide) 1 X X X X (Click on drug name to go to detailed view) BW C W P AR PPI/MG Capoten (Captopril) Tablets2 X X Coartem (Artemether/Lumefantrine) Tablets3 X X X Diovan (Valsartan) Tablets4 X X X X PCI Revatio (Sildenafil) Tablets, Oral Suspension and Injection5 X X X (Click on drug name to go to detailed view) BW C W P AR PPI/MG Atrovent HFA (Ipratropium Bromide HFA) Inhalation Aerosol6 X X Avelox (Moxifloxacin Hydrochloride) Tablet and Injection7 X X Bactrim (Sulfamethoxazole and Trimethoprim) Tablet and8Bactrim DS (Sulfamethoxazole and Trimethoprim) Double-Strength Tablet9 X Complera (Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate) Tablets10 X X Diovan HCT (Valsartan/Hydrochlorothiazide)11 X X X PCI Edurant (Rilpivirine) Tablets12 X X Fuzeon (Enfuvirtide) Injection13 X X PCI/PI Intelence (Etravirine) Tablets14 X X Invega Sustenna (Paliperidone Palmitrate) Extended-release Injectable Suspension15 X X X Isentress (Raltegravir) Tablets16 X X Lamictal (Lamotrigine) Tablets, Chewable Dispersible Tablets, Orally Disintegrating Tablets and Lamictal XR (Lamotrigine)17 X X Leustatin (Cladribine) Injection18 X X X Lovaza (Omega-3-Acid Ethyl Esters) Capsules19 X X Lucentis (Ranibizumab) Injection20 X X Mirapex (Pramipexole Dihydrochloride) and Mirapex ER (Pramipexole Dihydrochloride) Extended-release Tablets21 X X Moviprep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid) For Oral Solution22 X X Neoral Soft Gelatin (Cyclosporine) Capsule23Neoral oral Solution (Cyclosporine) Oral Solution24 X X X Nexavar (Sorafenib) Tablets25 X X X PI Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)26 X X Ortho Evra (Norelgestromin/Ethinyl Estradiol) Transdermal Patch27 X X PL Oxaliplatin (Oxaliplatin) for Injection28 X X Sanctura XR (Trospium Chloride) Extended-Release Capsules29 X X X Sandimmune (Cyclosporine, USP) Injection, Oral solution and Gelatin Capsules30 X X X Selzentry (Maraviroc) Tablets31 X X PCI/MG Strattera (Atomoxetine Hydrochloride) Capsules32 X X Sustiva (Efavirenz) Capsules and Tablets33 X X Toviaz (Fesoterodine Fumarate) Extended-Release Tablets34 X X X Tradjenta (Linagliptin) Tablets35 X X X Trobicin (Spectinomycin) for Injectable Suspension36 X Ultane and Ultane NovaPlus (Sevoflurane) Volatile Liquid for Inhalation37 X Vectibix (Panitumumab) Injection for Intravenous Infusion38 X X X Viread (Tenofovir Disoproxil Fumarate) Tablets and Powder39 X X (Click on drug name to go to detailed view) BW C W P AR PPI/MG Cimzia (Certolizumab Pegol) Lyophilized Powder or Solution 40 X Detrol (Tolterodine Tartrate) Tablets and Detrol LA (Tolterodine Tartrate) Extended-Release Capsules41 X PPI Effexor XR (Venlafaxine Hydrochloride) Extended-release Capsules42 X Rescriptor (Delavirdine Mesylate) Oral Tablets43 X PI Symbyax (Olanzapine and Fluoxetine HCL) Capsults44 X Zestoretic (Lisinopril and Hydrochlorothiazide) Tablets45 X Zestril (Lisinopril) Tablets46 X (Click on drug name to go to detailed view) BW C W P AR PPI/MG Combivent (Ipratropium Bromide and Albuterol Sulfate) Aerosol47 X Cymbalta (Duloxetine Hydrochloride) Capsules48 X PCI Demadex (Torsemide) Tablets49 X Dulera (Mometasone Furoate and Formoterol Fumarate Dihydrate) Inhalation Aerosol50 X Gralise (Gabapentin) Tablets51 X Kalydeco (Ivacaftor) 52 X Vesicare (solifenacin Succinate) Tablets53 X (Click on drug name to go to detailed view) BW C W P AR PPI/MG Felbatol (Felbamate) Tablets and Oral Suspension54 MG Zyprexa Relprevv (Olanzapine) for Extended-release Injectable Suspension55 MG