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U.S. Department of Health and Human Services

Safety

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June 2012

Drug 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  MG
CellCept (mycophenolate mofetil hydrochloride) for injection Intravenous
X
 X X   MG 
X
 X XX  
X
 XX  MG 
X
 XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Bepreve (bepotastine besilate) 1.5% ophthalmic solution X   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
  XX  
  X X 
  XX  
  X X   
  X X  X  
Prezista (darunavir) tablets and oral  XXXPPI
  XX  
  X X   
  XX  
  X X   
Zithromax (azithromycin) for Oral Suspension  X 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
Modicon (norethindrone/ethinyl estradiol)   X  
Ortho-Cept (desogestrel and ethinyl estradiol) Tablets   X  
   X  
Ortho-Novum (norethindrone/ethinyl estradiol) 1/35 Tablets   X  
Ortho-Novum (norethindrone/ethinyl estradiol) 7/7/7 Tablets   X  
   X  
   X  
   X  
   X X  
Zyflo (zileuton) Tablets   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
    
X
 
    
X
 
    
X
 
    
X
MG
Proventil HFA (albuterol sulfate) Inhalation Aerosol    
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
      MG 
      MG