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    X     
  X X X X  
  X    X     
  X   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  X  
    X      
FML Forte (fluorometholone) Ophthalmic Suspension     X      
    X  X  X PPI
    X  X   X   
    X   X  
    X X X  
    X X  X   
    X  X     
    X X    
    X X  
    X X    
    X X    
    X  X  X  
    X      
    X      
    X  X     
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
      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
 
       
X
 
        X  
        X  
 

Posted on the FDA website on 13 March 2013