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U.S. Department of Health and Human Services

Safety

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February 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

Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets X   X X X
PPI

Cleocin Sterile Solution (clindamycin injection)

Cleocin Phosphate (clindamycin injection in 5% dextrose) IV Sterile Solution

X  
X X  
 
Duragesic (fentanyl) Transdermal System
X
 
X
X
 
MG
Emsam (selegiline transdermal system) Patches
X
 
X
X
 
MG
Fentora (fentanyl buccal tablet) X        
MG
Lincocin (lincomycin) Injection
X
 
X
X
 
 

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Asmanex Twisthaler (mometasone furoate inhalation powder)   X X X
X
 

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Abilify (aripiprazole) Tablets and Oral Solution

Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets

Abilify (aripiprazole) Injection for Intramuscular Use Only

    X X
X
 
Avastin (bevacizumab) for Intravenous Use     X  
X
 
Claforan Sterile (cefotaxime sodium for injection, USP) and Injection (cefotaxime sodium injection, USP)     X X    
Cortenema (hydrocortisone retention enema)     X X    
Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets     X X    
Eryc (erythromycin delayed-release capsules, USP)     X X    
Erythrocin Lactobinate (erythromycin lactobionate) Injection, Powder, Lyophilized, For Solution     X X    
Geocillin (carbenicillin indanyl sodium) Tablets     X X    
Halcion (triazolam tablets)     X X   MG
Janumet (sitagliptin/metformin HCl) Tablets     X X   PPI
Letairis (ambrisentan) Tablets     X X
X
MG
Premarin Intravenous (conjugated estrogens, USP) for injection     X X
X
PPI
Remodulin (treprostinil sodium) Injection     X  
X
 
Restoril (temazepam) Capsules     X X   MG
Reyataz (atazanavir sulfate) Capsules     X  
X
PPI
Sensipar (cinacalcet) Tablets     X X
X
 
Ultram ER (tramadol HCl) Extended-Release Tablets     X X
X
 

Vibramycin Calcium (doxycycline calcium oral suspension, USP) Oral Suspension Syrup

Vibramycin Hyclate (doxycycline hyclate capsules, USP) Capsules

Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension

Vibra-Tabs (doxycycline hyclate tablets, USP) Film Coated Tablets

    X X    

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Arestin (minocycline HCl) Microspheres       X    

Avelox (moxifloxacin HCl) Tablets

Avelox I.V. (moxifloxacin HCl in NaCl injection)

      X X PPI
Corgard (nadolol tablets, USP)       X    
Daytrana (methylphenidate transdermal system)       X X MG
Diskets Dispersible Tablets (methadone hydrochloride tablets for oral suspension, USP)        X    
Ditropan (oxybutynin chloride) Tablets and Syrup      
X
X
 
Ditropan XL (oxybutynin chloride) Extended Release Tablets      
X
X
 
Effexor (venlafaxine hydrochloride) Tablets      
X
   
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules      
X
   
Lexiva (fosamprenavir calcium) Tablets and Oral Suspension      
X
   
Methadose Oral Concentrate (methadone hydrochloride oral concentrate USP)

Methadose Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP)
     
X
   

Nexium (esomeprazole magnesium) Delayed-Release Capsules

Nexium (esomeprazole magnesium) For Delayed-Rlease Oral Suspension

     
X
X
 

Tekturna (aliskren) Tablets

     
X
   
Trandate (labetalol hydrochloride) Tablets      
X
   
Viracept (nelfinavir mesylate) Tablets and Oral Powder      
X
   

(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Forteo teriparatide (rDNA origin) Injection        
X
 
MoviPrep (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) Oral Solution        
X
 
VESIcare (solifenacin succinate) Tablets        
X
 
Viagra (sildenafil citrate) Tablets        
X
 
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

Avandia (rosiglitazone maleate tablets)          
MG