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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- November 2007

 

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

Abilify (aripiprazole) Tablets

Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets

Abilify (aripiprazole) Oral Solution

Abilify (aripiprazole) Injection For Intramuscular Use Only

X

 
MG
Aranesp (darbepoetin alfa) For Injection
X
 
X
 
 
PPI
Avandia (rosiglitazone maleate) Tablets
X
 
X
X
X
PPI
Epogen (epoetin alfa) For Injection
X
 
X
X
  PPI
Myfortic (mycophenolic acid*) Delayed-Release Tablets
X
 
X
X
   
Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)
X
X
X
X
   
Sarafem (fluoxetine hydrochloride tablets)
X
 
X
X
  MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Crestor (rosuvastatin calcium) Tablets   X
X
X
X  
Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules  
X
X
X
X  
Kaletra (Iopinavir/ritonavir) Tablets and Solution  

X

X
X
X PPI
Lac-Hydrin (ammonium lactate) Lotion, 12%   X
X
 
 
 
Zometa (zoledronic acid) Injection - Concentrate for Intravenous Infusion   X
X
X
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Arava (leflunomide) Tablets     X
 
 
 
Avalide (irbesartan-hydrochlorothiazide) Tablets     X
X
X  
Celebrex (celecoxib capsules)     X
X
X  
Eligard (leuprolide acetate for injectable suspension)     X
X
X
 
Invanz (ertapenem for injection)     X
X
 
 
Motrin IB (200 mg ibuprofen) Tablets    
X
     
Nexavar (sorafenib) Tablets    
X
X
X
PPI
Sprycel (dasatinib) Tablet For Oral Use    
X
X
X
PPI
Toradol (ketorolac tromethamine tablets)    
X
X
X  
Vectibix (panitumumab) For Intravenous Use Only    
X
     
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Atrovent (ipratropium bromide) Nasal Spray       X
 
 
Chantix (varenicline) Tablets       X
X
PPI
Colazal (balsalazide disodium) Capsules       X
 
 
Cordarone (amiodarone HCl) Tablets       X
 
 
Emend (aprepitant) Capsules       X
 
 
Foscavir (foscarnet sodium) Injection       X
 
 

Levaquin (levofloxacin) Tablets and Oral Solution

Levaquin (levofloxacin) Injection, for Intravenous Use

Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use

      X
 
 
Omnaris (ciclesonide) Nasal Spray For Intranasal Use Only       X
X
PPI

Protonix (pantoprazole sodium) Delayed-Release Tablets

Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension

      X
X
 
Zevalin (ibritumomab tiuxetan)       X
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) Tablets        
X
 
Diovan (valsartan) Tablets         X PPI

Pepcid (famotidine) Injection Premixed

Pepcid (famotidine) Injection

       
X
 

Pepcid (famotidine) Tablets

Pepcid (famotidine) Oral Suspension

       
X
 
Pletal (cilostazol) Tablets        
X
 
Zocor (simvastatin) Tablets         
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Lovaza (omega-3-acid ethyl esters) Capsules
 
 
 
 
 
  PPI

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