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U.S. Department of Health and Human Services

Safety

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June 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

Optison (Perflutren Protein -Type A Microspheres Injectable Suspension, USP) X  
X
     
Viramune (nevirapine) Tablets and Oral Suspension
X
X
X
X
MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Aptivus (tipranavir) Capsules and Oral Solution   X X X
X
PPI
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets  

X

X X
X
PPI
Avodart (dutasteride) Soft Gelatin Capsules   X X X
X
 
Concerta (methylphenidate HCl) Extended-Release Tablets   X X X
X
MG

Kaletra (lopinavir and ritonavir) Tablet, Film Coated for Oral Use

Kaletra (lopinavir and ritonavir) Solution for Oral Use

  X   X X PPI
Reclast (zoledronic acid) Injection   X X X X PPI
Zyvox (linezolid) Injection
Zyvox (linezolid) Tablets
Zyvox (linezolid) for Oral Suspension
  X        
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Advil Allergy Sinus Caplets (ibuprofen, pseudoephedrine HCl, chlorpheniramine maleate)     X      
Advil Cold & Sinus (ibuprofen and pseudoephedrine HCl) Caplets     X      
Advil Cold & Sinus Liqui-Gels (ibuprofen and pseudoephedrine HCl) Capsules     X      
Advil Liqui-Gels (ibuprofen) Capsules     X      
Advil Migraine (ibuprofen) Capsules     X      
Advil PM (ibuprofen, diphenhydramine citrate) Caplets     X      
Advil PM Liqui-Gels (ibuprofen, diphenhydramine HCl) Capsules     X      
Advil (ibuprofen) Tablets     X      
Agrylin (anagrelide hydrochloride) Capsules     X X X  
Antara (fenofibrate) Capsules     X      
Celestone Soluspan (betamethasone sodium phosphate and betamethasone acetate Injectable Suspension, USP)     X X    

Children’s Advil Chewables (50 ibuprofen) Chewable Tablets

Junior Strength Advil Chewables (100 mg ibuprofen) Chewable Tablets

    X      
Children’s Advil (ibuprofen) Suspension     X      
Clozaril (clozapine) Tablets     X   X  
Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules     X X X  
Infants' Advil (ibuprofen) Concentrated Drops     X      
Junior Strength Advil (ibuprofen) Tablets     X      
Metvixia (methyl aminolevulinate) Cream, 16.8% For Topical Use Only     X X X PPI
Potassium Chloride Extended Release Tablets, USP     X X    
Pulmicort Flexhaler (budesonide inhalation powder) For Oral Inhalation Only     X X    
Synercid I.V. (quinupristin and dalfopristin for injection)     X X    
Vectibix (panitumumab) Injection For Intravenous Use     X X X  
Velcade (bortezomib) For Injection     X X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Amoxicillin/Clavulanate Potassium Tablets       X    
Amoxil (amoxicillin capsules, tablets, chewable tablets, and powder for oral suspension)       X
X
 
Doryx (doxycycline hyclate) Delayed-Release Tablets       X    
Ganirelix Acetate Injection       X
X
 
Levothyroxine Sodium Tablets, USP       X    
Ortho Micronor (norethindrone) Tablets       X    
Sarafem (fluoxetine hydrochloride) Capsules       X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Aciphex (rabeprazole sodium) Delayed Release Tablets        
X
PPI
Baraclude (entecavir) Tablets and Oral Solution        
X
PPI
Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]        
X
PPI
Genotropin (somatropin [rDNA origin] for injection)        
X
 
Mobic (meloxicam) Tablets and Oral Suspension        
X
 
OxyContin (oxycodone HCl controlled-release) Tablets        
X
 
Spiriva HandiHaler (tiotropium bromide inhalation powder)         X PPI
Vytorin (ezetimibe/simvastatin) Tablets         X PPI
Zetia (ezetimibe) Tablets         X PPI

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Byetta (exenatide) Injection          
PPI
Forteo (teriparatide [rDNA origin]) Injection          
MG
PegIntron/REBETOL Combo Pack containing: PegIntron REDIPEN Single-dose Delivery System (peginterferon alfa-2b) and REBETOL (ribavirin, USP) Capsules          
MG