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U.S. Department of Health and Human Services

Safety

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April 2011

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
Aplenzin (bupropion hydrobromide) Extended-Release TabletsX XXXPCI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Fosrenol (lanthanum carbonate) Chewable Tablets XXX X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Advil (ibuprofen) Infants oral suspension   X    
Advil (ibuprofen) tablets  X   
Advil Liqui-Gels (ibuprofen) capsules  X   
Advil PM (ibuprofen 200 mg/diphenhydramine citrate 38 mg) tablets   X    
Advil PM Liqui-Gels (ibuprofen 200 mg/diphenhydramine hydrochloride 25 mg) capsules  X   
Aleve (naproxen sodium) tablets   X    

Chorionic Gonadotropin for Injection

  X   

Combivent (ipratropium bromide and albuterol sulfate) Aerosol

  XX 
Cyanokit (hydroxocobalamin for Injection)  XX  
Demerol (meperidine hydrochloride)  XXX 
Eligard (leuprolide acetate) injectable suspension  X X   

Fuzeon (enfuvirtide) for Injection

  X X   
Gleevec (imatinib mesylate) Tablets  XXX 

Invega (paliperidone) extended-release tablets

  X X   

Janumet (sitagliptin/metformin hydrochloride) Tablets

  X X  X MG
Januvia (sitagliptin) Tablets  XXXMG
Lysteda (tranexamic acid) Tablets  X X   

Novarel (chorionic gonadotropin for Injection, USP)

  X   
Omnitrope (somatropin [rDNA origin] injection)  XX  

Pregnyl (chorionic gonadotropin for Injection, USP)

  X   

Zemplar (Paricalcitol) Injection

  XX X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Aclovate (alclometasone dipropionate) Cream   X  
Aptivus (tipranavir) Capsules and Oral Solution   X  

Diflucan (fluconazole) Tablets and I.V.

   X  

Exjade (deferasirox) Tablets for Oral Suspension

   X  
Kytril (granisetron hydrochloride) Intravenous Injection
   X  
Pexeva (paroxetine mesylate) Tablets
   X MG

Qualaquin (quinine sulfate USP) Capsules

   X  

Voltaren Ophthalmic (diclofenac sodium ophthalmic solution)

   X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Aredia (pamidronate disodium) for Injection

    
X
PPI 
Arimidex (anastrozole) Tablets    X 

Cymbalta (duloxetine hydrochloride)

    
X
PPI 
Isentress (raltegravir potassium) Tablets    
X
 
Propecia (finastride) Tablet    
X
 

Prozac (fluoxetine hydrochloride)

Prozac Weekly (fluoxetine hydrochloride)

    
X
 

Relpax (eletriptan) Tablets

    
X
 

Singulair (montelukast sodium) Tablets, Chewable Tablets and Oral Granules

    
X
PPI 

Symbyax (olanzapine and fluoxetine HCL) Capsules

    
X
PCI 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
MoviPrep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride,
Sodium Ascorbate, and Ascorbic Acid for Oral Solution)
     MG
Pristiq (desvenlafaxine) Extended-Release Tablets     MG

Rythmol SR Extended-Release Capsules

     PPI