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U.S. Department of Health and Human Services

Safety

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March 2014

Drug Safety Labeling Changes

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
Stavzor (Valproic acid) Delayed Release Capsules 
X
 XXX 
Xarelto (rivaroxaban) Tablets, 10 mgX XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Diflucan (fluconazole) Injection and Powder for Oral Suspension  XXX  
Evamist (estradiol transdermal spray)  XXXX 
Sodium Iodide I-131 Therapeutic Solution X  X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Azulfidine (sulfasalazine tablets, USP) and Azulfidine EN-Tablets (sulfasalazine delayed release tablets, USP)  XXX 
Erwinaze (asparaginase Erwinia chrysanthemi)   XX  
Herceptin (trastuzumab)   XX  
Jevtana (cabazitaxel) Injection  XXX 
Miacalcin (calcitonin-salmon) Nasal Spray and Injection, Synthetic  XXX 
Nexium (esomeprazole sodium) for Intravenous Injection, Delayed-Release Capsules, and Delayed-Release Oral Suspension  XX  
Prilosec (omeprazole) Delayed-Release Capsules and Oral Suspension   XX  
Selzentry (maraviroc) Tablets   XX  
Revatio (sildenafil) Tablets, Injection and Oral Suspension    XX  
Ultane (sevoflurane) and Ultane NovaPlus (sevoflurane) volatile liquid for inhalation   X   
Viagra (sildenafil citrate) Tablets  XX  
Vimovo (naproxen/esomeprazole magnesium) Delayed-Release Tablets   XX  
Xeljanz (tofacitinib) Tablets   XX  
Xifaxan (rifaximin) Tablets   XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Caprelsa (vandetanib)    X  
Diovan (valsartan) Tablets and Capsules     XX 
Diovan HCT (valsartan/hydrochlorothiazide) Tablets    XX 
Exforge (amlodipine/valsartan) Tablets    XX 
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) Tablets    XX 
Spectazole (econazole nitrate) cream    X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Clarinex D 12-HOUR and 24-HOUR Extended Release Tablets    X 
Keppra (levetiracetam) Tablets, Extended Release Tablets, Oral Solution and Injection     
X
 
ProQuad Measles, Mumps, Rubella and Varicella Virus Vaccine Live    
X
 
Proscar (finasteride) tablets     
X
 
Varivax Varicella Virus Vaccine Live      X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG