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U.S. Department of Health and Human Services

Safety

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June 2009

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
Prometrium (progesterone, USP) 100 and 200 mg Capsules X   X X X PPI
Reglan (metoclopramide) tablets, ODT (Orally Disintegrating Tablets), and injection X   X     MG
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Coreg (carvedilol) 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg tablets   X     X PPI
Prandin (repaglinide) tablets   X   X    
Videx (didanosine) pediatric powder and Videx EC capsules   X   X    
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Amaryl (glimepiride) tablets     X X X  

Aristospan (triamcinolone hexacetonide injectable suspension, USP) 5 mg/mL and 20 mg/mL Parenteral

    X      
Cancidas (caspofungin acetate) 50mg/vial and 70 mg/vial for Injection     X X X  
CellCept (mycophenolate mofetil) Capsules, Tablets, Injection and Suspension     X X X MG
Combivent (ipratropium bromide and albuterol sulfate) Inhalation Aerosol     X      
Coreg CR (carvedilol phosphate) 10 mg, 20 mg, 40 mg, and 80 mg Extended Release Capsules     X X   PPI
Patanase (olopatadine hydrochloride) nasal spray     X X X  
Rocephin (ceftriaxone sodium) for injection, 250 mg, 500 mg, 1g and 2g     X      
Strattera (atomoxetine hydrochloride) 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg capsules       X X X  
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Aptivus (tipranavir) 250 mg capsules and 100 mg/mL oral solution       DI    
Aralen (chloroquine phosphate, USP) 500 mg tablets       X X  
BenzaClin Topical Gel (clindamycin 1%- benzoyl peroxide gel 5%)       X X  
Coly-Mycin S Otic (colistin sulfate-neomycin sulfate-thonzonium bromide-hydrocortisone acetate) otic suspension       X    
Covera-HS (verapamil hydrochloride) Extended Release tablets       X    
Entocort EC (budesonide) Capsules       X X  
Natrecor (nesiritide) for Injection       X X  
Nexium (esomeprazole magnesium) for Delayed Release Oral Suspension       X    
Prezista (darunavir) tablets       DI   PPI

Sanctura (trospium chloride) 20 mg 

Sanctura XR (trospium chloride extended release) 60mg capsules 

      X    
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Cozaar (losartan potassium) 25 mg, 50 mg, and 100 mg Tablets        
X
 
Diovan (valsartan) 40 mg, 80 mg, 160 mg, and 320 mg Tablets        
X
 
Hyzaar (losartan potassium hydrochlorothiazide) 50-12.5 mg, 100-12.5 mg, and 100-25 mg Tablets        
X
 
Lupron Depot (leuprolide acetate for depot suspension) 3.75 mg and 11.25 mg Injection        
X
 
Stromectol (ivermectin) 3 mg Tablets           X  
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Salonpas Pain Relief Patch (10% methyl salicylate & 3% 1-menthol) [OTC]           Label
Tylenol 8-Hour (650 mg acetaminophen) extended-release tablets [OTC]           Label