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U.S. Department of Health and Human Services

Safety

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March 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

Aranesp (darbepoetin alfa) for Injection X  
     
Epogen (epoetin alfa) for Injection
X
 
X
     

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Avodart (dutasteride) Soft Gelatin Capsules   X    
PPI
Reyataz (atazanavir sulfate) Capsules   X X X
PPI
Tussionex Pennkinetic (hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension   X X X
 

Vfend I.V. (voriconazole) for Injection

Vfend Tablets (voriconazole)

Vfend (voriconazole) for Oral Suspension

  X   X   PPI

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Aczone (dapsone) Gel, 5%     X X   PPI

Advair HFA 45/21 (fluticasone propionate 45 mcg and salmeterol 21 mcg*) Inhalation Aerosol

Advair HFA 115/21 (fluticasone propionate 115 mcg and salmeterol 21 mcg*) Inhalation Aerosol

Advair HFA 230/21 (fluticasone propionate 230 mcg and salmeterol 21 mcg*) Inhalation Aerosol

    X X   MG
Amoxil (amoxicillin capsules, tablets, chewable tablets, and powder for oral suspension)     X X    
Augmentin (amoxicillin/clavulanate potassium) Powder for Oral Suspension and Chewable Tablets     X X    
Augmentin (amoxicillin/clavulanate potassium) Tablets     X X    
Depakote ER (divalproex sodium) Extended Release Tablets     X X    
Depakote (divalproex sodium) Sprinkle Capsules     X X    
Invanz (ertapenem for injection)     X X    
Merrem I.V. (meropenem for injection) for Intravenous Use Only     X X X  
Monurol (fosfomycin tromethamine) Sachet     X X    
NovoLog (insulin aspart [rDNA origin] injection) Solution for Subcutaneous Use     X X X PPI
Penicillin G Potassium Injection, USP     X X    
Premarin Intravenous (conjugated estrogens, USP) for Injection     X X X PPI
Premarin (conjugated estrogens tablets, USP)     X X X PPI
Premarin (conjugated estrogens) Vaginal Cream in a nonliquefying base     X X X PPI

Prempro (conjugated estrogens/medroxyprogesterone acetate tablets)

Premphase (conjugated estrogens/medroxyprogesterone acetate tablets)

    X X X  
Prezista (darunavir) Tablets     X X X PPI
Primaxin I.M. (imipenem and cilastatin for injectable suspension)     X X    
Primaxin I.V. (imipenem and cilastatin for injection)     X X    
Sandostatin LAR Depot (octreotide acetate for injectable suspension)     X X X  
Serevent Diskus (salmeterol xinafoate inhalation powder)     X X   MG
Zevalin (ibritumomab tiuxetan) Injection for Intravenous Use     X X X  

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate (butalbital, acetaminophen, caffeine, and codeine Phosphate) Capsules       X    
Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules       X    
Flolan (epoprostenol sodium) for Injection       X    
Pexeva (paroxetine mesylate) Tablets       X    
Ponstel (mefenamic acid capsules, USP)       X   MG
Prozac (fluoxetine capsules, USP)       X    
Septra I.V. Infusion (trimethoprim and sulfamethoxazole)       X    

Septra Tablets (trimethoprim and sulfamethoxazole tablets)

Septra DS Tablets (trimethoprim and sulfamethoxazole double-strength tablets)

Septra Suspension (trimethoprim and sulfamethoxazole suspension)

Septra Grape Suspension (trimethoprim and sulfamethoxazole grape suspension)

      X    
Symbyax (olanzapine and fluoxetine HCl capsules)       X    
Tigan (trimethobenzamide hydrochloride) Capsules       X    
Urex (methenamine hippurate) Tablets       X    
Ventolin HFA (albuterol sulfate) Inhalation Aerosol       X    
Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate       X    
Zometa (zoledronic acid) Injection Concentrate for Intravenous Infusion       X    

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Abilify (aripiprazole) Tablets and Oral Solution

Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets

Abilify (aripiprazole) Injection for Intramuscular Use Only

       
X
 
Avastin (bevacizumab) for Intravenous Use        
X
 
Azmacort (triamcinolone acetonide) Inhalation Aerosol        
X
 
Levitra (vardenafil HCl) Tablets        
X
 
PegIntron and Rebetol (peginterferon alfa-2b and ribavirin)        
X
MG
Moban (molindone hydrochloride tablets, USP)        
X
 
Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules         X  
Ventavis (iloprost) Inhalation Solution         X PPI