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U.S. Department of Health and Human Services

Safety

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January 2010

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 INFROMATION

 
         
DRUG NAME
SECTIONS MODIFIED
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Exjade (deferasirox) tablets for oral suspension X X X X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Aristocort Forte (triamcinolone diacetate) injectable suspension   X X X X  
Boniva (ibandronate sodium) tablets   X X X    
Effexor (venlafaxine HCl) tablets and Effexor XR (venlafaxine HCl) extended-release capsule   X     X  
Invirase (saquinavir mesylate) capsules and tablets   X X X X  
Kaletra (lopinavir/ritonavir) oral solution and tablets   X   X   PCI
RotaTeq (rotavirus vaccine, live, pentavalent) oral solution   X     X PPI
Tykerb (lapatinib) tablets   X     X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Cancidas (caspofungin acetate) for injection     X X    
Cardene (nicardipine hydrochloride) premixed injection     X X X  
Coumadin (warfarin sodium) tablet and injection     X      
Crestor (rosuvastatin calcium) tablets     X X    
Kenalog (triamcinolone acetonide) injectable suspension     X      
Pexeva (paroxetine mesylate) tablets     X      
R-Gene 10 (arginine hydrochloride) injection     X   X  
Remodulin (treprostinil) injection     X X X  
Symbyax (olanzapine and fluoxetine hydrochloride) capsules     X X X  
Toprol-XL (metoprolol succinate) extended release tablets     X X X  
Videx EC (didanosine) delayed release capsules and Videx(didanosine) pediatric powder for oral solution     X X   PCI
Viramune (nevirapine) oral suspension and tablets     X X   PCI
Zyprexa (olanzapine) tablets, orally disintegrating tablets and IM injection     X      
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Clozaril (clozapine HCl) tablets       X X  
Reyataz (atazanavir sulfate) capsules       X   PPI
Sandostatin (octreotide acetate) injection and Sandostatin LAR Depot Injection       X    
Uniretic (moexipril hydrochloride and hydrochlorothiazide) tablets       X    
Univasc (moexipril hydrochloride) tablets       X    
Viagra (sildenafil citrate) tablets       X    
Zostavax (zoster vaccine live) suspension for subcutaneous injection       X   PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets         X  
Bumex (bumetanide) tablets        
X
 
Demadex (torsemide) tablets        
X
 
Ethrane (enflurane) liquid for inhalation         X  
Indocin I.V. (indomethacin) injection         X  
Rapamune (sirolimus) tablets and oral solution         X PCI
Ultane (sevoflurane) liquid for inhalation         X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Cardura (doxazosin mesylate) tablets           PPI