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U.S. Department of Health and Human Services

Safety

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March 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
Epzicom (abacavir sulfate and lamivudine) tablets
X
X
X
 
MG 
OsmoPrep (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets
X
     
X
MG
Raptiva (efalizumab)
X
X
X
X
X
MG
Sporanox (itraconazole) Oral Solution, 10 mg/mL
X
X
X
X
X
 
Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets
X
X
X
X
  MG
Visicol (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP)
X
     
X
MG
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Diabeta (glyburide) Tablets  
X
  X    
Macrobid (nitrofurantoin monohydrate/macrocrystals) capsules, 100 mg  
X
       
Macrodantin (nitrofurantoin macrocrystals) capsules, 25, 50 and 100 mg   X X      
Rocephin (ceftriaxone sodium) for injection, 250 mg, 500 mg, 1 g and 2 g  
X
X  
X
 
Sporanox (itraconazole) Capsules, 100 mg  
X
X X X PPI
Sporanox (itraconazole) Injection, 10 mg/mL  
X
X X
X
PPI
Theophylline in 5% Dextrose injection, USP, Flexible Plastic Container  
X
X X X  
Tracleer (bosentan) 62.5 and 125 mg Tablets  
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 xinafoate inhalation powder)     X X    

Altace (ramipril) 1.25, 2.5, 5, and 10 mg Capsules

Altace (ramipril) 1.25, 2.5, 5 and 10 mg Tablets

    X X    
Axert (almotriptan malate) Tablets 6.25 and 12.5 mg     X X
X
PPI
Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules 20, 30 and 60 mg     X X X MG
Frova (frovatriptan succinate) Tablets 2.5 mg     X X
X
X
Lexiscan (regadenoson) Injection     X X
X
 
Spiriva HandiHaler inhalation powder     X  
X
X
(Click on drug name to go to detailed view)

BW

C

W P AR PPI/MG
NegGram (nalidixic acid) Caplets       X    
Novothyrox (levothyroxine sodium) Tablets       X    
Tarka (trandolopril/verapamil hydrochloride) 2/180, 1/240, 2/240, 4/240 mg ER Tablets       X    
Zithromax (azithromcyin) for Oral Suspension, 200 mg, 500 mg, Single Dose Packet, 600 mg, IV       X    
(Click on drug name to go to detailed view) BW C W P AR PPI/MG
Clinoril (sulindac) Tablets        
X
 
Cosmegen (dactinomycin) for Injection        
X
 
Crestor (rosuvastatin calcium) Tablets          X  
Demerol (meperidine hydrochloride) Tablets and Oral Solution        
X
 

Eloxatin (oxaliplatin) powder for solution for intravenous use

Eloxatin (oxaliplatin) concentrate for solution for intravenous use

       
X
 
Lipitor (atorvastatin calcium) Tablets        
X
 
Niaspan (niacin extended release) tablet         X  
Vancocin Hcl (vancomycin for injection, USP) 500 mg/100mL and 1g/200mL        
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Dalmane (flurazepam hydrochloride), 15 mg and 30 mg oral Capsules            
MG
Prozac (fluoxetine hydrochloride) capsules            
MG
Symbyax (olanzapine/fluoxetine) capsules            
MG
Synagis (palivizumab)          
PPI

Zyprexa (olanzapine) Tablet

Zyprexa Zydis (olanzapine) Tablet, Orally Disintegrating

           
MG