Drug Safety Labeling Changes - August 2012

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August 2012

This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.

Key to Label Sections
BW - Boxed Warning C - Contraindications W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert MG - Medication Guide PCI - Patient Counseling Information

Sections Modified
Drug Name BW C W P AR PPI MG PCI
Aplenzin (Bupropion Hydrobromide)Boxed WarningContraindicationsWarningsPrecautions----
Capoten (Captopril) Tablets-Contraindications-Precautions----
Diovan (Valsartan) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Revatio (Sildenafil) Tablets, Oral Suspension and Injection-ContraindicationsWarningsPrecautions----
Atrovent HFA (Ipratropium Bromide HFA) Inhalation Aerosol--WarningsPrecautions----
Avelox (Moxifloxacin Hydrochloride) Tablet and Injection--WarningsPrecautions----
Bactrim (Sulfamethoxazole and Trimethoprim) Tablet and--Warnings-----
Bactrim DS (Sulfamethoxazole and Trimethoprim) Double-Strength Tablet--Warnings-----
Complera (Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate) Tablets--WarningsPrecautions----
Diovan HCT (Valsartan/Hydrochlorothiazide)--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Fuzeon (Enfuvirtide) Injection--WarningsPrecautions----
Invega Sustenna (Paliperidone Palmitrate) Extended-release Injectable Suspension--WarningsPrecautionsAdverse Reactions---
Isentress (Raltegravir) Tablets--WarningsPrecautions----
Lamictal (Lamotrigine) Tablets, Chewable Dispersible Tablets, Orally Disintegrating Tablets and Lamictal XR (Lamotrigine)--WarningsPrecautions----
Leustatin (Cladribine) Injection--WarningsPrecautionsAdverse Reactions---
Lovaza (Omega-3-Acid Ethyl Esters) Capsules--WarningsPrecautions----
Lucentis (Ranibizumab) Injection--WarningsPrecautions----
Mirapex (Pramipexole Dihydrochloride) and Mirapex ER (Pramipexole Dihydrochloride) Extended-release Tablets--WarningsPrecautions----
Moviprep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid) For Oral Solution--WarningsPrecautions----
Neoral Soft Gelatin (Cyclosporine) Capsule--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Neoral oral Solution (Cyclosporine) Oral Solution--WarningsPrecautionsAdverse Reactions---
Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)--Warnings-Adverse Reactions---
Ortho Evra (Norelgestromin/Ethinyl Estradiol) Transdermal Patch--WarningsPrecautions----
Oxaliplatin (Oxaliplatin) for Injection--WarningsPrecautions----
Sanctura XR (Trospium Chloride) Extended-Release Capsules--WarningsPrecautionsAdverse Reactions---
Sandimmune (Cyclosporine, USP) Injection, Oral solution and Gelatin Capsules--WarningsPrecautionsAdverse Reactions---
Toviaz (Fesoterodine Fumarate) Extended-Release Tablets--WarningsPrecautionsAdverse Reactions---
Trobicin (Spectinomycin) for Injectable Suspension--Warnings-----
Ultane and Ultane NovaPlus (Sevoflurane) Volatile Liquid for Inhalation--Warnings-----
Vectibix (Panitumumab) Injection for Intravenous Infusion--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Viread (Tenofovir Disoproxil Fumarate) Tablets and Powder--WarningsPrecautions----
Cimzia (Certolizumab Pegol) Lyophilized Powder or Solution---Precautions----
Detrol (Tolterodine Tartrate) Tablets and Detrol LA (Tolterodine Tartrate) Extended-Release Capsules---Precautions-Patient Package Insert--
Rescriptor (Delavirdine Mesylate) Oral Tablets---Precautions----
Symbyax (Olanzapine and Fluoxetine HCL) Capsults---Precautions----
Zestoretic (Lisinopril and Hydrochlorothiazide) Tablets---Precautions----
Combivent (Ipratropium Bromide and Albuterol Sulfate) Aerosol----Adverse Reactions---
Cymbalta (Duloxetine Hydrochloride) Capsules----Adverse Reactions---
Demadex (Torsemide) Tablets----Adverse Reactions---
Dulera (Mometasone Furoate and Formoterol Fumarate Dihydrate) Inhalation Aerosol----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Gralise (Gabapentin) Tablets----Adverse Reactions---
Kalydeco (Ivacaftor)----Adverse Reactions---
Felbatol (Felbamate) Tablets and Oral Suspension--------
Zyprexa Relprevv (Olanzapine) for Extended-release Injectable Suspension--------
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