• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

April 2013

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

BW

C

W

P

AR

PPI/MG
*Bisphosphonate Drugs
   X X  
*Bisphosphonate Drugs
   X X  
*Bisphosphonate Drugs
   XX 

Binosto (Alendronate Sodium) Effervescent Tablets

*Bisphosphonate Drugs
   X X  
*Bisphosphonate Drugs
   X X  
   X  
*Bisphosphonate Drugs
   X X  
*Bisphosphonate Drugs
   X X  
*Bisphosphonate Drugs
   X  X   
   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
    
X
 
    
X
 
    
X
 
    
X
 
    
X
 
Sonata (Zaleplon) Capsules    
X
 
    
X
 
    
X
 
    
X
 
    X 
    X 
    XPCI