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U.S. Department of Health and Human Services

Safety

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May 2008

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

 

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

BW

C

W

P

AR

PPI/MG
Definity (perflutren lipid microsphere) Injectable Suspension X  
X
 
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Ambien (zolpidem tartrate) Tablets   X X X
MG
Ceftriaxone for Injection and Dextrose Injection  

X

X X
 
Mirena (levonorgestrel-releasing intrauterine system)   X X X
PPI
Noxafil (posaconazole) Oral Suspension   X   X   PPI
Valium (diazepam) Tablets   X X X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Accolate (zafirlukast) Tablet, Film Coated     X      
Caduet (amlodipine besylate/atorvastatin calcium) Tablets     X X    

CellCept (mycophenolate mofetil capsules)

CellCept (mycophenolate mofetil tablets)

CellCept Oral Suspension (mycophenolate mofetil for oral suspension)

CellCept Intravenous (mycophenolate mofetil hydrochloride for injection)

    X  
 
Chantix (varenicline) Tablets     X X   MG
Furadantin (nitrofurantoin) Oral Suspension     X X    
Hepsera (adefovir dipivoxil) Tablets     X X
 
Herceptin (trastuzumab) Intravenous Infusion     X X
 
Intron A (interferon alfa-2b, recombinant) For Injection     X     MG
Keflex (cephalexin) Capsules     X X    
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   PPI
Mycobutin (rifabutin capsules, USP)     X X    
Myfortic (mycophenolic acid) Delayed-Release Tablets     X   X  
Primaxin I.M. (imipenem and cilastatin for injectable suspension)     X X    
Primaxin I.V. (imipenem and cilastatin) For Injection     X X    
Strattera (atomoxetine hydrochloride) Capsules     X X 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    
Aranesp (darbepoetin alfa) For Injection       X X  
Argatroban Injection       X    

Biaxin Filmtab (clarithromycin tablets, USP)

Biaxin XL Filmtab (clarithromycin extended-release tablets)

Biaxin Granules (clarithromycin for oral suspension, USP)

      X    
Dexedrine (dextroamphetamine sulfate) Spansule Sustained-Release Capsules       X   MG
E.E.S. (erythromycin ethylsuccinate)       X    
Ery-Ped (erythromycin ethylsuccinate, USP)       X    
Inderal (propranolol hydrochloride) Tablets       X    
Inspra (eplerenone) Tablets       X    
Lotensin (benazepril hydrochloride) Tablets       X
X
 
Lotensin HCT (benazepril hydrochloride and hydrochlorothiazide, USP)       X
X
 
Malarone (atovaquone and proguanil hydrochloride) Tablets       X    
Mepron (atovaquone) Suspension       X
X
 
PCE (erythromycin particles in tablets) Dispertabs Tablets       X    
Sensipar (cinacalcet) Tablets       X    
Tekturna (aliskiren) Tablets       X   PPI

Timentin (ticarcillin disodium and clavulanate potassium) Injection

Galaxy (PL 2040) Plastic Container

      X    

Timentin (sterile ticarcillin disodium and clavulanate potassium) for Intravenous Administration

(Pharmacy Bulk Package - Not for Direct Infusion)

      X    

Vfend I.V. (voriconazole) for Injection

Vfend (voriconazole) Tablets

Vfend (voriconazole) for Oral Suspension

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

BW

C

W

P

AR

PPI/MG
Effexor (venlafaxine hydrochloride) Tablets        
X
 
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules        
X
 
Emtriva (emtricitabine) Capsules and Oral Solution        
X
 

Geodon (ziprasidone HCl) Capsules

Geodon (ziprasidone mesylate) for Injection For IM Use Only

       
X
 
Haldol (brand of haloperidol injection)For Immediate Release        
X
 
Haldol Decanoate (haloperidol) For IM Injection Only         X  
Invega (paliperidone) Extended-Release Tablets         X  
Lariam (mefloquine hydrochloride) Tablets         X  
Levitra (vardenafil hydrochloride) Tablets         X  
Seroquel (quetiapine fumarate) Tablets         X  
Seroquel XR (quetiapine fumarate) Extended-Release Tablets         X  
Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets         X  
Uroxatral (alfuzosin HCl extended-release tablets)         X  
Viread (tenofovir disoproxil fumarate) Tablets         X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Actos (pioglitazone HCl) Tablets          
PPI