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U.S. Department of Health and Human Services

Safety

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August 2013

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 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
 XX X MG 
 X    
 X    
Strattera (Atomoxetine Hydrochloride) Capsules XXX  
 X X  X   
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
  X X   
  X X  X  MG 
  XXXMG
  XXXMG
  XXXMG
  X X  X  
Crestor (Rosuvastatin Calcium) Tablets  X X  X  
  X X   
  X X  MG
  X X  X  
  X   
  X X   X MG
  X   
  X X   
  X X  X  MG 
  X X   
  XX  
  X X   
  XXX 
  XX  
  X X   
(Click on drug name to go to detailed view)

BW

C

W

P

AR

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

BW

C

W

P

AR

PPI/MG
    
X
 
    
X
 
    
X
 
    X 
Reyataz (Atazanavir Sulfate) Capsules    
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
     MG