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U.S. Department of Health and Human Services

Safety

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June 2011

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
Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules
*APAP class change
X     
Talacen (pentazocine hydrochloride and acetaminophen) tablets
*APAP class change
X
     
Ultracet (tramadol HCl/acetaminophen) tablets
*APAP class change
X
     
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Simcor (niacin extended-release/simvastatin) tablets XXXX 
Sumavel DosePro (sumatriptan) injection for subcutaneous use X    
Vytorin (ezetimibe/simvastatin) tablets XXXX 
Zmax (azithromycin extended release) for oral suspension XXXX 
Zocor (simvastatin) tablets XXXX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Avalide (irbesartan/hydrochlorothiazide) tablets

  XX  
Avodart (dutasteride) soft gelatin capsules  XX  
Corgard (nadolol) tablets  X   
Corzide (nadolol and bendroflumethiazide) tablets  X   
Diflucan (fluconazole) tablets, I.V, and oral suspension  X   

Ditropan XL (oxybutynin chloride) tablets

  XX  
Diovan (valsartan) tablets  XX PCI

Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) tablets
*eye problems

  X   
Feraheme (ferumoxytol) injection  XX  
Jalyn (dutasteride and tamsulosin) capsules  XX  
Kenalog-10 (triamcinolone acetonide) injection and Kenalog-40 (triamcinolone acetonide) injection  X X 
Nexium (esomeprazole magnesium) for delayed-release oral suspension,  delayed-release capsules and (esomeprazole sodium) for injection  XXXPCI/PPI

Photofrin (porfimer sodium) for injection

  X X  X  

Prilosec (omeprazole magnesium) for delayed-release oral suspension and delayed-release capsules

  X X  PPI
Proscar (finasteride) tablets  X X   

Prozac Pulvules (fluoxetine hydrochloride) capsules for oral use and Prozac Weekly (fluoxetine hydrochloride) delayed-release capsules

  X X  X  
Renagel (sevelamer hydrochloride) tablets and Renvela (sevelamer carbonate) powder for oral suspension and tablets  XX  

Tekturna HCT (aliskiren/hydrochlorothiazide) tablets

*eye problems

  XXX 
Torisel (temsirolimus) injection  XX  

Venofer (iron sucrose) injection

  XX  
Vimovo (naproxen/esomeprazole magnesium) tablets  XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Atacand (candesartan cilexetil) tablets and Atacand HCT (candesartan/cilexetil hydrochlorothiazide) tablets
*NSAID interaction

   X  

Benicar (olmesartan medoxomil) tablets
*NSAID interaction

   X  

Calan (verapamil hydrochloride) tablets

   X X  

Diovan (valsartan) tablets 

*NSAID interaction

   X  
Dilacor XR (diltiazem hydrochloride) extended release capsules    X  
Invega Sustenna (paliperidone palmitate) extended-release injectable suspension   X  

Lotensin HCT (benazepril HCl and hydrochlorothiazide) tablets

*NSAID interaction

   X  

Lotrel (amlodipine besylate and benazepril hydrochloride) tablets

*NSAID interaction

   X  

Pepcid (famotidine) tablets

   XX 

Propecia (finasteride) 1 mg tablet

   XX 
Tribenzor (olmesartan medoxomil / amlodipine / hydrochlorothiazide) tablets   X  

Twynsta (telmisartan/amlodipine) tablets   

*NSAID interaction

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

BW

C

W

P

AR

PPI/MG

Busulfex (busulfan) injection

    
X
 
Lupron Depot (leuprolide acetate) suspension    
X
 
Multaq (dronedarone hydrochloride) tablets    
X
 
Mycamine (micafungin sodium) for injection    
X
 
Neulasta (pegfigrastim) injection    
X
 
Risperdal (risperidone) tablets, oral solution, Risperdal M-Tab (risperidone) orally disintegrating tablets, and Risperdal Consta (risperidone) long-acting injection.    
X
 
Temodar (temozolomide) for Injection; vial and capsules    
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Lyrica (pregabalin) capsules and oral solution     MG 
Omeprazole delayed-release tablets [OTC generic]     PCI