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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2008

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
 
Proair HFA (albuterol sulfate) Inhalation Aerosol  
X
X
X
X
 

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
 
 
 
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
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
Pegasys (peginterferon alfa-2a)
 
 
 
 
 

MG 

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