miércoles, 17 de octubre de 2012

Drug Safety Labeling Changes > September 2012

Drug Safety Labeling Changes > September 2012



September 2012

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
PCI=PATIENT COUNSELING INFORMATION

DRUG NAME
SECTIONS MODIFIED
(Click on drug name to go to detailed view)
BW
C
W
P
AR
PPI/MG
Exjade (deferasirox) Tablets1 
X
X X X X  
(Click on drug name to go to detailed view)
BW
C
W
P
AR
PPI/MG
*Dual Blockade of the RAS   X      
*Dual Blockade of the RAS   X   X    
Arcapta Neohaler (indacaterol maleate) Inhalation Powder 75 mcg4   X X X X MG
*Dual Blockade of the RAS   X   X    
*Dual Blockade of the RAS   X   X    
*Dual Blockade of the RAS   X   X    
*Dual Blockade of the RAS   X   X    
*Dual Blockade of the RAS   X   X    
Doxil (doxorubicin HCl liposome injection) for intravenous infusion, single dose vial: 20 mg/10 mL and 50 mg/25 mL10    X        
Exforge (amlodipine/valsartan) 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg Tablets11   X X X X PPI
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) Tablets12   X X X X PCI
*Dual Blockade of the RAS   X    X    
Juvisync (sitagliptin/simvastatin) Tablets, 100mg/10mg, 100 mg/20 mg, 100mg/40mg, 50mg/10mg, 50 mg/20 mg, and 50mg/40mg14   X X X X MG
*Dual Blockade of the RAS   X   X    
*Dual Blockade of the RAS   X   X    
*Dual Blockade of the RAS   X   X    
Multaq (dronedarone hydrochloride) 400 mg Tablets18    X X MG
Ozurdex (dexamethasone intravitreal implant) 0.7 mg19         
*Dual Blockade of the RAS   X   X    
*Dual Blockade of the RAS   X   X    
*Dual Blockade of the RAS   X   X    
*Dual Blockade of the RAS   X   X    
*Dual Blockade of the RAS   X   X    
*Dual Blockade of the RAS   X   X    
*Dual Blockade of the RAS     X    
*Dual Blockade of the RAS   X   X    
(Click on drug name to go to detailed view)
BW
C
W
P
AR
PPI/MG
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), 100 milligram vial28     X X X PCI
Aggrenox (aspirin/extended release dipyridamole) 25 mg/200 mg Capsules29      X X  
Cefepime for Injection USP and Dextrose Injection USP in the Duplex Container
Cefepime Injection in the GALAXY Container for intravenous use
30 
    X X  
*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)     X    
Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg32      X MG
Lovaza (omega 3-acid ethyl esters) Capsules33     X X   PPI
Maxipime (cefepime hydrochloride) for Injection34     X X X  
*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)     X X    
*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)     X X    
*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)     X X    
*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)     X X    
*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)     X X    
Trilipix (fenofibric acid) Delayed Release Capsules40      X X X  
*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)     X X    
Xgeva (denosumab)42     X X    
Xyzal (levocetirizine dihydrochloride) 5mg tablets and 2.5mg/5ml solution43      X X PCI
Zomig (zolmitriptan) tablets
Zomig-ZMT (zolmitriptan) orally disintegrating tablets
44
    X X    
(Click on drug name to go to detailed view)
BW
C
W
P
AR
PPI/MG
Glyset (miglitol) Tablets, 25 mg, 50 mg and 100 mg45        X  
Voltaren Opthalmic (diclofenac sodium ophthalmic solution) 0.1%46        X  
(Click on drug name to go to detailed view)
BW
C
W
P
AR
PPI/MG
Cayston (aztreonam for inhalation solution)47         
X
 
Singulair (Montelukast Sodium) 10 mg Tablets, 5 mg and 4 mg Chewable Tablets, and 4mg Oral Granules48          X  
Tradjenta (linagliptin) tablets, 5 mg49         X  
Ventolin HFA (albuterol sulfate) Inhalation Aerosol50         X  
Xopenex (levalbuterol HCl) Inhalation Solution Concentrate, 1.25 mg/0.5 mL51         X  
Zytiga (abiraterone acetate) Tablets52         X  
(Click on drug name to go to detailed view)
BW
C
W
P
AR
PPI/MG
AndroGel (testosterone gel) 1.62%53            MG
CellCept (mycophenolate mofetil) Capsules, Tablets, Oral Suspension and CellCept (mycophenolate mofetil hydrochloride) for Injection54           MG
Clobex (clobetasol propionate) Spray, 0.05%55            PPI
Micardis (telmisartan) 20, 40, and 80 mg Tablets56           PPI
Myfortic (mycophenolic acid) delayed-release tablets57           MG
Prolia (denosumab)58           MG
 

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