Drug Safety Labeling Changes - March 2014

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March 2014

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
Stavzor (Valproic acid) Delayed Release CapsulesBoxed Warning-WarningsPrecautionsAdverse Reactions---
Xarelto (rivaroxaban) Tablets, 10 mgBoxed Warning-WarningsPrecautions----
Diflucan (fluconazole) Injection and Powder for Oral Suspension-ContraindicationsWarningsPrecautions----
Evamist (estradiol transdermal spray)-ContraindicationsWarningsPrecautionsAdverse Reactions---
Sodium Iodide I-131 Therapeutic Solution-Contraindications--Adverse Reactions---
Azulfidine (sulfasalazine tablets, USP) and Azulfidine EN-Tablets (sulfasalazine delayed release tablets, USP)--WarningsPrecautionsAdverse Reactions---
Erwinaze (asparaginase Erwinia chrysanthemi) --WarningsPrecautions----
Herceptin (trastuzumab)--WarningsPrecautions----
Jevtana (cabazitaxel) Injection--WarningsPrecautionsAdverse Reactions---
Miacalcin (calcitonin-salmon) Nasal Spray and Injection, Synthetic--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Nexium (esomeprazole sodium) for Intravenous Injection, Delayed-Release Capsules, and Delayed-Release Oral Suspension--WarningsPrecautions----
Prilosec (omeprazole) Delayed-Release Capsules and Oral Suspension--WarningsPrecautions----
Selzentry (maraviroc) Tablets--WarningsPrecautions----
Revatio (sildenafil) Tablets, Injection and Oral Suspension  --WarningsPrecautions----
Ultane (sevoflurane) and Ultane NovaPlus (sevoflurane) volatile liquid for inhalation--Warnings-----
Viagra (sildenafil citrate) Tablets--WarningsPrecautions----
Vimovo (naproxen/esomeprazole magnesium) Delayed-Release Tablets--WarningsPrecautions----
Xeljanz (tofacitinib) Tablets--WarningsPrecautions----
Xifaxan (rifaximin) Tablets--WarningsPrecautions----
Caprelsa (vandetanib)---Precautions----
Drug Name BW C W P AR PPI MG PCI
Diovan (valsartan) Tablets and Capsules---PrecautionsAdverse Reactions---
Diovan HCT (valsartan/hydrochlorothiazide) Tablets---PrecautionsAdverse Reactions---
Exforge (amlodipine/valsartan) Tablets---PrecautionsAdverse Reactions---
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) Tablets---PrecautionsAdverse Reactions---
Spectazole (econazole nitrate) cream---Precautions----
Clarinex D 12-HOUR and 24-HOUR Extended Release Tablets----Adverse Reactions---
Keppra (levetiracetam) Tablets, Extended Release Tablets, Oral Solution and Injection ----Adverse Reactions---
ProQuad Measles, Mumps, Rubella and Varicella Virus Vaccine Live----Adverse Reactions---
Proscar (finasteride) tablets ----Adverse Reactions---
Varivax Varicella Virus Vaccine Live----Adverse Reactions---
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