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U.S. Department of Health and Human Services

Safety

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December 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 NAMESECTIONS MODIFIED
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Avandamet (rosiglitazone maleate and metformin hydrochloride) TabletsX 
X
X
 
X
Avandaryl (rosiglitazone maleate and glimepiride) Tablets
X
 
X
X
 X
Myozyme (alglucosidase alfa) For Intravenous Infusion Only
X
 
X
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Arimidex (anastrozole) Tablets XXX
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Avelox Tablets and Injection   X 
 X
 
Celebrex (celecoxib) Capsules  XX  
Children’s Advil Cold (ibuprofen 100 mg and pseudoephedrine HCL 15 mg/5 ml) suspension  X  
Crixivan (indinavir sulfate)  XX  
Delsym (dextromethorphan polistirex) Extended-Release Suspension, 30 mg/5 mL  X   
Dianeal Peritoneal Dialysis Solution in Plastic Container, PL-146, 1.5%, 2.5% and 4.25% Dextrose  X  
Ethyol Injection  
X
X
 
Innohep (tinzaparin sodium injection)  
X
 X
X
Lipofen (fenofibrate) Capsules  
X
X
  
OMNICEF (cefdinir) capsules, 300 mg and OMNICEF (cefdinir) oral suspension, 125 mg/5mL and 250 mg/5mL  
X
 
 
Rifater (rifampin, isoniazid and pyrazinamide) Tablets  
X
 
X
Sensipar (cinacalcet HCl) Tablets  
X
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Actos (pioglitazone hydrochloride) Tablets

   
X
  
Apokyn (apomorphine hydrochloride) 10mg/mL and Apokyn (apomorphine) Injection   
 X
 
Aredia (pamidronate disodium for injection) For Intravenous Infusion   
X
 
Coreg (carvedilol) Tablets   
X
  
Coreg CR (carvedilol phosphate) Extended-Release Capsules   
X
  
E.E.S. 200 Liquid (erythromycin ethylsuccinate for oral suspension) Suspension
E.E.S. 400 Liquid (erythromycin ethylsuccinate for oral suspension) Suspension
E.E.S. Granules (erythromycin ethylsuccinate for oral suspension) Granule, For Suspension
E.E.S. 400 Filmtab Tablets (erythromycin ethylsuccinate tablets) Tablet, Film Coated
Eryped 200 (erythromycin ethylsuccinate) Suspension
Eryped 400 (erythromycin ethylsuccinate) Suspension
Eryped Drops (erythromycin ethylsuccinate) Suspension
   
X
  
Eldepryl (selegiline hydrochloride) Capsules   
X
  
Eldepryl (selegiline hydrochloride) Tablets   
X
  
Elmiron (pentosan polysulfate sodium) Capsules   
X
  
Famvir (famciclovir) Tablets 125, 250, 500 mg   
X
  
Mirapex (pramipexole dihydrochloride) Tablets     X  
PCE (erythromycin) Tablet    X  

Prilosec (omeprazole) Delayed-Release Capsules

Prilosec (omeprazole magnesium) for Delayed-Release Oral Suspension

   X  
Requip (ropinirole) Tablets    X  
Sinemet (carbidopa/levodopa) Tablets   X  
Sinemet CR (carbidopa/levodopa) Tablets    X  
Symmetrel (amantadine hydrochloride) Syrup    X  
Zelapar (selegiline hydrochloride) Orally Disintegrating Tablets   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Augmentin (amoxicillin/clavulanate potassium) Powder for Oral Suspension and Chewable Tablets    
X
 
Augmentin (amoxicillin/clavulanate potassium) Tablets    
X
 
Augmentin XR (amoxicillin/clavulanate potassium) Extended Release Tablets    
X
 
Enablex (darifenacin hydrobromide) Extended-Release Tablets    
X
 
Malarone (atovaquone and proguanil hydrochloride) Tablets    
X
 
Meridia (sibutramine hydrochloride monohydrate) Capsules    X 
OsmoPrep, (sodium phosphate monobasic monohydrate, USP & sodium phosphate dibasic anhydrous, USP) Tablets     X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Aromasin (exemestane tablets)      X

CellCept (mycophenolate mofetil capsules and tablets)

CellCept Oral Suspension (mycophenolate mofetil for oral suspension)

CellCept Intravenous (mycophenolate mofetil hydrochloride for injection)

     
X
Flomax (tamsulosin hydrochloride) Capsules     X
Myfortic (mycophenolic acid) Delayed-release Tablets     
X
Pegasys (interferon alfa 2a)     
X
PegIntron (peginterferon alfa-2b) in combination with Rebetol (ribavirin)     
X
Toradol Oral (ketorolac tromethamine) Tablets      
X
Zerit (stavudine) Capsules
Zerit (stavudine) for Oral Solution
     
X