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U.S. Department of Health and Human Services

Safety

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September 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
Aceon (perindopril erbumine) Tablets X  
 X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

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

BW

C

W

P

AR

PPI/MG

EpiPen (epinephrine) Auto-Injector 0.3 mg

EpiPen JR (epinephrine) Auto-Injector 0.15 mg

   
X
X
X
 
Erbitux (cetuximab) Solution for Intravenous Use    
X
X
X
 
Exubera (insulin human [rDNA origin]) Inhalation Powder    
X
   
MG
Gleevec (imatinib mesylate) Tablets    
X
X
X
 
Heparin Sodium Injection, USP [Preservative Free]    
X
X
   
Heparin Sodium Injection, USP [Preserved with Parabens]    
X
X
   
Nasacort AQ (triamcinolone acetonide) Nasal Spray    
X
X
X
PPI
Noroxin (norfloxacin) Tablets    
X
X
X
PPI
Photofrin (porfimer sodium) Injection    
X
X
X
 
Reyataz (atazanavir sulfate) Capsules    
X
X
X
PPI
Rituxan (rituximab) Injection for Intravenous Use    
X
X
   
Tarceva (erlotinib) Tablets    
X
X
X
 
Uroxatral (alfuzosin HCl extended-release tablets)    
X
     
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Capoten (captopril tablets, USP)      
X
   
Celexa (citalopram hydrobromide) Tablets and Oral Solution       
X
   
Detrol (tolterodine tartrate tablets)      
X
 
PPI
Detrol LA (tolterodine tartrate extended release capsules)      
X
 
PPI
Glucovance (glyburide and metformin HCl tablets)      
X
   
Invega (paliperidone) Extended-Release Tablets      
X
   
Lariam (mefloquine hydrochloride) Tablets      
X
X
MG
Lexapro (escitalopram oxalate) Tablets and Oral Solution      
X
   
Stromectol (ivermectin) Tablets      
X
   
Vaseretic (enalapril maleate and hydrochlorothiazide) Tablets      
X
   
Vasotec (enalapril maleate) Tablets      
X
   
Ventavis (iloprost) Inhalation Solution      
X
X
 
Videx EC (didanosine, USP) Delayed-Release Capsules (Enteric-Coated Beadlets)      
X
 
PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Adagen (pegademase bovine) Injection        
X
 
Alimta (pemetrexed disodium) Injection, Powder, Lyophilized, For Solution for Intravenous Use        
X
PPI
Curosurf (poractant alfa) Intratracheal Suspension        
X
 
Lybrel (90 mcg levonorgestrel and 20 mcg ethinyl estradiol) Tablets        
X
PPI
NeoProfen (ibuprofen lysine) Injection        
X
 
Retrovir (zidovudine) Tablets, Capsules, and Syrup        
X
 
Valtrex (valacyclovir hydrochloride) Caplets        
X
PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Pegasys (peginterferon alfa-2a)           MG