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U.S. Department of Health and Human Services

Safety

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November 2008

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
Premarin (conjugated estrogens) Vaginal Cream
X
X
X
X
X
PPI 
Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets
X
 
X
X
X
PPI
Viread (tenofovir disoproxil fumarate) Tablets
X
 
X
X
X
PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Promethazine HCl and Codeine Phosphate Oral Solution  
X
X
X
  
Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution  

X

X
X
  
Ranexa (ranolazine) Extended-Release Tablets  
X
X
X
X
 
Sucraid (sacrosidase) Oral Solution 
X
   
PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Aldactone (spironolactone tablets, USP)   
X
   
Avastin (bevacizumab) For Intravenous Use  
X
X
X
 
Boniva (ibandronate sodium) Tablets   
X
X
X
PPI
Ethyol (amifostine) For Injection  
X
X
X
 
Selzentry (maraviroc) Tablets  
X
X
X
 
Triglide (fenofibrate) Tablets   
X
X
  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Clozaril (clozapine) Tablets    
X
X
 
Combivent Inhalation Aerosol (ipratropium bromide and albuterol sulfate)   
X
X
PPI
Emend (aprepitant) Capsules   
X
  
Neulasta (pegfilgrastim)   
X
  
Qualaquin (quinine sulfate) Capsules, USP    
X
  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
VESIcare (solifenacin succinate) Tablets    
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Accutane (isotretinoin capsules)     
MG
Adderall XR (dextroamphetamine mixed salts of a single-entity amphetamine product) Capsules     
MG
Levemir (insulin detemir [rDNA origin] injection)              
PPI
Levemir (insulin detemir [rDNA origin] injection) FlexPen      
MoviPrep (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) Oral solution     
PPI
NovoLog (insulin aspart [rDNA origin] injection)     
PPI
NovoLog (insulin aspart [rDNA origin] Injection) FlexPen     
PPI
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin])      
PPI
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) FlexPen     
PPI
Pegasys (peginterferon alfa-2a)     
MG
Viracept (nelfinavir mesylate) Tablets and Oral Powder     
PPI
Vyvanse (lisdexamfetamine dimesylate) Capsules     
MG