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U.S. Department of Health and Human Services

Safety

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July 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
Baraclude (entecavir) Tablets and Oral Solution
X
 
X
X
 
Exforge (amlodipine and valsartan) Tablets
X
 
X
X
 
PPI
Strattera (atomoxetine hydrochloride) Capsules
X
 
X
X
X
MG
Tykerb (lapatinib) Tablets
X
 
X
X
X
PPI
Ziagen (abacavir sulfate) Tablets and Oral Solution
X
X
X
X
X
MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Advair HFA (fluticasone propionate and salmeterol) Inhalation Aerosol for Oral Inhalation Only    
X
 
   
MG
Avandia (rosiglitazone maleate) Tablets    
X
X
X
 
Diovan HCT (valsartan and hydrochlorothiazide USP) Tablets    
X
X
X
PPI
FazaClo (clozapine, USP) Orally Disintegrating Tablets    
X
 
X
 
Januvia (sitagliptin) Tablets    
X
X
  
 

Lopressor (metoprolol tartrate) Tablets

Lopressor (metoprolol tartrate) Injection, Solution

   
X
 
 
X
 
Lopressor HCT (metoprolol tartrate USP and hydrochlorothiazide USP) Tablets    
X
 
X
 
Lovenox (enoxaparin sodium injection) for Subcutaneous and Intravenous Use    
X
X
X
 
Mirena (levonorgestrel-releasing intrauterine system)    
X
X
X
PPI
Primaquine (primaquine phosphate tablets, USP)    
X
 
 
 
Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets    
X
X
 
PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Cancidas (caspofungin acetate) for Injection (Intravenous Use Only)      
X
X
  
Capastat Sulfate (capreomycin for injection, USP) for Intramuscular and Intravenous Infusion Only      
X
X
 
Colazal (balsalazide disodium) Capsules      
X
X
 
Coreg (carvedilol) Tablets      
X
  
 
Duac Topical Gel (clindamycin, 1% - benzoyl peroxide, 5%)      
X
X
 
Flovent HFA (fluticasone propionate) Inhalation Aerosol for Oral Inhalation Only      
X
   
PPI
Fortamet (metformin hydrochloride) Extended-Release Tablets      
X
 
 
Levoxyl (levothyroxine sodium) Tablets      
X
 
 
Natacyn (natamycin ophthalmic suspension) 5%      
X
X
 
Prandin (repaglinide) Tablets       
X
 
 
Starlix (nateglinide) Tablets      
X
 
 
Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for Oral Inhalation Only      
X
 
MG
Synthroid (levothyroxine sodium tablets, USP)      
X
  
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) [albumin-bound]        
X
 
Imuran (azathioprine) 50 mg Tablets and 100 mg (as the sodium salt) for Intravenous Injection        
X
 
Simcor (simvastatin/niacin extended-release) Tablet, Film Coated, Extended Release for Oral Use        
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
EC-Naprosyn (naproxen delayed-release tablets)
Naprosyn (naproxen tablets)
Anaprox/Anaprox DS (naproxen sodium tablets)
Naprosyn (naproxen suspension)
         
MG
Enbrel (etanercept) for Subcutaneous Injection          
MG
Vicoprofen (hydrocodone bitartrate/ibuprofen) Tablets          
MG