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U.S. Department of Health and Human Services

Safety

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December 2012

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
X
XXX PCI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
(Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)
 X X    
(Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)
 X X   MG
(Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)
 X X    MG
(Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)
 XX  
 XX  
(Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)
 XX  
(Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)
 XX  
 X X  MG 
(Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)
 XX PCI 
 X X   
 XX  
(Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)
 XX  
 X   MG
(Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)
 XX   
 X X  X   
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
  X X  
  X X  
  X X  PCI 
  XX   
  XX X  
  X X   
  X  
Sabril (Vigabatrin) Tablets  X X   
  X X   
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
   X  
   X  
   X  
   X  
   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
    
X
 
    
X
 
    
X
 
Nizoral (Ketoconazole) 2% Shampoo    
X
 
    
X
 
    
X
 
    
X
 
    
X
 
    
X
 
    
X
 
    
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
     MG