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August 2012

Publish Date: Fri, 14 Sep 2012 14:00:00 -0400

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
XX X   
(Click on drug name to go to detailed view)

BW

C

W

P

AR

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

BW

C

W

P

AR

PPI/MG
  XX  
  XX  
  X   
  X X   
Diovan HCT (Valsartan/Hydrochlorothiazide)  X X  X PCI 
  X X   
  XX PCI/PI 
  X X   
  X X X 
  X X   
  X X   
  XXX 
  XX  
  X X   
  X X   
  X X   
  X X X 
  X X XPI 

Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

  X X 
  X X  PL 
  X X   
  X X  X  
  XX X  
  XX PCI/MG 
Strattera (Atomoxetine Hydrochloride) Capsules  X X   
Sustiva (Efavirenz) Capsules and Tablets  XX  
  XX X  
  X X X 
  X   
  X   
  XX 
  X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

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

BW

C

W

P

AR

PPI/MG
    
X
 
    
X
PCI 
    
X
 
    
X
 
Gralise (Gabapentin) Tablets    
X
 
    
X
 
    
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
     MG 
Zyprexa Relprevv (Olanzapine) for Extended-release Injectable Suspension     MG 
 
    

 



http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm315860.htm

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