• 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 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 XX PCI 
Altace (Ramipril) CapsulesX XX PCI 
X
 X X   
X
XXX PI 
X
 XX  MG 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
 XXX PCI 
 XXXX 
*Concomitant use with ARBs or ACEIs in diabetes
 XXXXPCI 
Premarin (Conjugated Estrogens,USP) for Injection X X   PPI
*Concomitant use with ARBs or ACEIs in diabetes
 XX X  X  PCI 
*Concomitant use with ARBs or ACEIs in diabetes
 XX X  X  PCI 
*Concomitant use with ARBs or ACEIs in diabetes
 XX X  X  PCI 
 XX X   
 XX X   
 XXX PPI 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
  XX PCI
  X X   
  X X   
  X X   
  X X PI
  X X   
  X X X 
  XX  
  X X  PCI 
  X X  X MG
  X X  X  
  X X   
  X X  X MG
  X X   
  XX  
*Venous thromboembolism (VTE) Risk
  XX PCI
*Venous thromboembolism (VTE) Risk
  XX PCI
  XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

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

BW

C

W

P

AR

PPI/MG
    
X
 
*Tremors
    
X
 
    
X
 
    
X
 
    
X
 
    
X
 
    
X
 
    XPI