Drug Safety Labeling Changes - July 2013

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July 2013

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
Depakene (valproic acid) Capsules and Oral SolutionDepakote (divalproex sodium) Delayed ReleaseDepakote ER (Extended Release) TabletsDepakote Sprinkle Capsules (divalproex sodium coated particles in capsules)Depacon (valproate sodium) InjectionBoxed WarningContraindicationsWarningsPrecautions----
Nizoral (ketoconazole) TabletsBoxed WarningContraindicationsWarnings-----
Nucynta (tapentadol) Immediate-Release (IR) Oral Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Prolia (denosumab)-ContraindicationsWarningsPrecautions----
Rapaflo (silodosin) Capsules-Contraindications--Adverse Reactions---
Sarafem (fluoxetine hydrochloride) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Agrylin (anagrelide hydrochloride) Capsules--Warnings-Adverse Reactions---
Azor (amlodipine/olmesartan medoxomil) Tablets--Warnings-----
Azulfidine EN-Tablets (sulfasalazine delayed release tablets, USP)--WarningsPrecautionsAdverse Reactions---
Bactrim and Bactrim DS Tablets--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Benicar (olmesartan medoxomil)--WarningsPrecautionsAdverse Reactions---
Benicar HCT (olmesartan medoxomil/ hydrochlorothiazide) Tablets--WarningsPrecautionsAdverse Reactions---
Dulera (mometasone furoate/formoterol fumarate) Inhalation Aerosol--WarningsPrecautionsAdverse Reactions---
Elspar (asparaginase)--WarningsPrecautionsAdverse Reactions---
Geodon (ziprasidone) Capsules, Injection and Oral Suspension--WarningsPrecautions----
Lupron Depot (Leuprolide Acetate for Depot Suspension)--WarningsPrecautionsAdverse Reactions---
MultiHance (gadobenate dimeglumine) Injection and MultiHance Multipack (gadobenate dimeglumine) Injection--WarningsPrecautions----
Tribenzor (olmesartan medoxomil/ amlodipine/ hydrochlorothiazide) Tablets--WarningsPrecautionsAdverse Reactions---
Vivitrol (naltrexone for extended-release injectable suspension)--WarningsPrecautions----
Abilify (aripiprazole) Tablets, Oral Solution, Orally Disintegrating Tablets, and Injectable Formulation---Precautions----
Drug Name BW C W P AR PPI MG PCI
Procardia (nifedipine) Capsules---Precautions----
Procardia XL (nifedipine) Tablets---Precautions----
Tenex (guanfacine hydrochloride) Tablets---Precautions----
Clozaril (clozapine) Oral Tablets----Adverse Reactions---
Eloxatin (oxaliplatin) Injection ----Adverse Reactions---
INVANZ (ertapenem) Injection, 1 gm----Adverse Reactions---
Keppra (levetiracetam) Tablets, XR tablets, Oral Solution, Injection----Adverse Reactions---
Oracea (doxycycline) Capsules----Adverse Reactions---
Viread (tenofovir disoproxil fumarate) Oral Powder, 40 mg/gram----Adverse Reactions---
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