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August 2012

Posted Sep 14 2012 2:00pm

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

 
     
PPI/MGPPI/MGPPI/MGPPI/MGPPI/MGPPI/MG
DRUG NAME
SECTIONS MODIFIED
(Click on drug name to go to detailed view)BW

C

W

P

AR

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

C

W

P

AR

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

C

W

P

AR

  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

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

C

W

P

AR

    
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

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