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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 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
Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets X
X
X
X
X
PPI
Campath (alemtuzumab) Injection for Intravenous Use
X
 
X
X
X
 

CellCept (mycophenolate mofetil capsules) (mycophenolate mofetil tablets)

CellCept Oral Suspension (mycophenolate mofetil for oral suspension)

CellCept Intravenous (mycophenolate mofetil hydrochloride for injection)

X
 
X
X
X
 
Diovan HCT (valsartan and hydrochlorothiazide, USP) Tablets
X
 
X
X
 
 
Duetact (pioglitazone HCl plus glimepiride)
X
X
X
X
X
PPI
Evista (raloxifene hydrochloride) Tablets for Oral Use
X
 
X
X
X MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

MDP Multidose Kit for the Preparation of Technetium Tc99m Medronate Injection

  X X  
X
 

MDP Multidose Utilipak Kit for the Preparation of Technetium Tc99m Medronate Injection

 

X

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

BW

C

W

P

AR

PPI/MG
Avastin (bevacizumab) for Intravenous Use     X  
X
 
Butisol Sodium (butabarbital sodium tablets, USP and butabarbital sodium oral solution, USP) Tablets and Oral Solution     X X
 
 
Cefazolin for Injection, USP and Dextrose Injection, USP     X X
 
 
CefOTAXime for Injection, USP and Dextrose Injection     X X
 
 
CefTRIaxONE for lnjection and Dextrose lnjection     X X
 
 
CefUROXime for Injection, USP and Dextrose Injection, USP     X X
 
 

Cefzil (cefprozil) Tablets

Cefzil (cefprozil) for Oral Suspension

    X X
 
 
Gleevec (imatinib mesylate) Tablets for Oral Use     X X
X
 
Haldol brand of haloperidol injection (for Immediate Release)     X      

Haldol Decanoate 50 (haloperidol) for IM Injection Only

Haldol Decanoate 100 (haloperidol) for IM Injection Only

    X      
HalfLytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed release tablets)     X X X PPI
Keppra (levetiracetam) Injection for Intravenous Use     X X X  

Levaquin (levofloxacin) Tablets and Oral Solution

Levaquin (levofloxacin) Injection for Intravenous Use

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

    X X X PPI
Lipitor (atorvastatin calcium) Tablets     X X    
Neupogen (filgrastim)     X X   PPI
Norditropin Cartridges [somatropin (rDNA origin) injection], for Subcutaneous Use     X X X PPI
Soma (carisoprodol) Tablets for Oral Use     X X X  
Taxotere (docetaxel) Injection Concentrate, Intravenous Infusion     X X X PPI
Vancomycin Hydrochloride (vancomycin hydrochloride) Injection, Solution for Intravenous Use Only     X X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Actos (pioglitazone hydrochloride) Tablets       X
 
 
Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets       X
 
PPI
Avandaryl (rosiglitazone maleate and glimepiride) Tablets       X
X
PPI
Avandia (rosiglitazone maleate) Tablets       X
 
PPI
Caduet (amlodipine besylate/atorvastatin calcium) Tablets       X
X
 
Dovonex (calcipotriene cream) Cream, 0.005%       X
 
 
Dovonex (calcipotriene ointment), 0.005%       X
 
 
Dovonex (calcipotriene solution) Scalp Solution, 0.005%       X
 
 
Effexor (venlafaxine hydrochloride) Tablets       X
X
 
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules       X
X
 
Epivir-HBV (lamivudine) Tablets and Oral Solution       X
 
PPI
Inderal (propranolol hydrochloride) Tablets       X
 
 
Kaletra (lopinavir/ritonavir) Capsules and Oral Solution       X
 
 
Kaletra (lopinavir/ritonavir) Tablets and Oral Solution       X
 
 
Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets       X
X
PPI
Voltaren Ophthalmic (diclofenac sodium ophthalmic solution) 0.1%       X
X
 
Zebeta (bisoprolol fumarate) Tablets       X
 
 
Ziac (bisoprolol fumarate and hydrochlorothiazide) Tablets       X
 
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Abilify (aripiprazole) Tablets and Oral Solution

Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets

Abilify (aripiprazole) Injection for Intramuscular Use Only

       
X
 
Anzemet (dolasetron mesylate) Injection        
X
 
Anzemet (dolasetron mesylate) Tablets        
X
 
Benicar (olmesartan medoxomil)        
X
 
BuSpar (buspirone HCl, USP) Tablets        
X
 
Keppra (levetiracetam) Tablets and Oral Solution         X  
Lupron Injection (leuprolide acetate)         X  
OsmoPrep (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP)         X  
Rituxan (rituximab)         X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Humulin R Regular U-500 (Concentrated) Insulin Human Injection, USP (rDNA Origin) 
 
 
 
 
 
PPI

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