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U.S. Department of Health and Human Services

Safety

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April 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

Aldurazyme (laronidase) Solution for Intravenous Infusion Only X   X   X  
Emtriva (emtricitabine) Capsules and Oral Solution
X
 
    PPI
Lotronex (alosetron hydrochloride) Tablets
X
 
X
X
MG

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Advair Diskus (fluticasone propionate and salmeterol inhalation powder)   X X X
X
MG
Amitiza (lubiprostone) Capsules   X X X X  
Crixivan (indinavir sulfate) Capsules   X X X   PPI
Tigan (trimethobenzamide hydrochloride) Injectable for Intramuscular Use Only   X   X    

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Actonel (risedronate sodium) Tablets     X X
X
PPI
Augmentin (amoxicillin/clavulanate potassium)Tablets     X X    
Augmentin ES-600(amoxicillin/clavulanate potassium) Powder for Oral Suspension     X X    
Augmentin XR(amoxicillin/clavulanate potassium) Extended Release Tablets     X X    
Declomycin (demeclocycline hydrochloride) Tablets     X X    
Evamist (estradiol transdermal spray)     X X    

Levaquin (levofloxacin) Tablets and Oral Solution

Levaquin (levofloxacin) Injection, for Intravenous Use

Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use

    X X X PPI
Luvox (fluvoxamine maleate) Tablets     X X    
Nafcillin Injection, USP in PL 2040 Plastic Container For Intravenous Use Only - Galaxy Container (PL 2040 Plastic)     X X    
Neulasta (pegfilgrastim)     X   X PPI
Orencia (abatacept) Lyophilized Powder for Intravenous Infusion     X X X PPI
Oxacillin (oxacillin) Injection, Solution in Plastic Container For Intravenous Use Only - Galaxy Container (PL 2040)     X X    
Pipracil (piperacillin for injection) for Intravenous and Intramuscular Use     X X    

Prevacid (lansoprazole) Delayed-Release Capsules

Prevacid (lansoprazole) Delayed-Release Oral Suspension

Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets

    X X X  
Timentin (ticarcillin disodium and clavulanate potassium) for Intravenous Administration     X X    
Timentin (ticarcillin disodium and clavulanate potassium) Injection - Galaxy (PL 2040) Plastic Container     X X    
Unasyn (ampicillin sodium/sulbactam sodium)     X X    
Vyvanse (lisdexamfetamine dimesylate) Capsules     X X X  
Zosyn (piperacillin and tazobactam injection) in Galaxy Containers (PL 2040 Plastic)     X X    

Zosyn (piperacillin and tazobactam for injection) Individual Vials

Zosyn (piperacillin and tazobactam for injection) Pharmacy Bulk Package

    X X    

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Cardiolite Kit for the Preparation of Technetium Tc99m Sestamibi for Injection       X    
Cetrotide (cetrorelix acetate for injection)       X    
Dibenzyline (phenoxybenzamine hydrochloride capsules, USP)       X    
Fiorinal with Codeine (butalbital, aspirin, caffeine, and codeine phosphate) Capsules       X    
Maxitrol (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension       X    
Pilopine HS (pilocarpine hydrochloride ophthalmic gel) 4%       X    
Propranolol Hydrochloride Injection, USP       X    
Pulmicort Flexhaler (budesonide inhalation powder) For Oral Inhalation Only       X
X
PPI
Synthroid (levothyroxine sodium tablets, USP)       X    
Tenormin (atenolol) Tablets       X    

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Copegus (ribavirin, USP) Tablets        
X
 
Enablex (darifenacin) Extended-Release Tablets        
X
 
Flomax (tamsulosin hydrochloride) Capsules        
X
 
Lexiva (fosamprenavir calcium) Tablets and Oral Suspension         X PPI
Navane (thiothixene) Capsules
Navane (thiothixene hydrochloride) Concentrate
        X  
RotaTeq (rotavirus vaccine, live, oral, pentavalent) Oral Solution        
X
PPI

Singulair (montelukast sodium) Granule

Singulair (montelukast sodium) Tablet, Chewable

Singulair (montelukast sodium) Tablet, Film Coated

        X PPI
Theophylline in 5% Dextrose Injections, USP         X  

Zerit (stavudine) Capsules

Zerit (stavudine) for Oral Solution

        X PPI

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

NuvaRing (etonogestrel/ethinyl estradiol vaginal ring)          
  PPI