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U.S. Department of Health and Human Services

Safety

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October 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 X    
 X  X   
 XXX 
 X X X  
Diovan (valsartan) and Diovan HCT (valsartan/hydrochlorothiazide) Tablets X  X   
 X  X   
Edarbyclor (azilsartan medoxomil/chlorthalidone) Tablets X X  
 X  XMG
 X X  X  X  
 X  X   
 X X    
 X X    MG 
 X X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)
  X X   
  X X   
*IMNM label change
  X X  X  
  X X   
*IMNM label change
  X X X 
*IMNM label change
  X X  X PCI 
  XX  
  XX X  
*IMNM label change
  X X  X  
  X X X 
  X X   
*IMNM label change
  X X X 

Lescol XL (fluvastatin sodium) Extended-Release Tablets

*IMNM label change

  X X  X  
*IMNM label change
  XXX 
*IMNM label change
  X X  X  
*IMNM label change
  X X  X  
*Clopidogrel interaction
  XX  
*Clopidogrel interaction
  XX  
  X X   
*IMNM label change
  X X  X  
  X X  X  
*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)
  X X   
*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)
  X X   
*IMNM label change
  X X X 
  X X  MG/PCI 
  X X   
  X X   
*Clopidogrel interaction
  X X    
*IMNM label change
  X X  X  
*IMNM label change
  X X  X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
   X  
   X  
Savella (milnacipran HCl) tablets   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
 
    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
      PPI