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U.S. Department of Health and Human Services

Safety

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January 2011

Safety Label 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
Carbatrol (carbamazepine) Extended-Release Capsules X X MG

EES (erythromycin ethylsuccinate) Granules for Oral Suspension

Ery-Ped (erythromycin ethylsuccinate) Liquids

 XXXX 
PCE (erythromycin particles in tablets) Dispertab Tablet XXXX 
Gelnique (oxybutynin chloride) 10% gel  XX   
Uloric (febuxostat tablets)  X XX 
Zithromax (azithromycin) tablet, single-dose packet, IV for injection, and oral suspension  XX X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Actonel (risedronate sodium) tablets

* Bisphosphonates Class Label Change

  XX MG

Actonel with Calcium (risedronate sodium with calcium carbonate tablets, USP)

* Bisphosphonates Class Label Change

  XX MG

Atelvia (risedronate sodium) delayed-release tablets

* Bisphosphonates Class Label Change

  XX MG

Boniva (ibandronate sodium) tablets

* Bisphosphonates Class Label Change

  XX MG

Coreg (carvedilol) Tablets

Coreg CR (carvedilol phosphate) Extended Release Capsules 

  X PCI
Cyklokapron (tranexamic acid) Injection   X   

Folotyn (pralatrexate) Injection 

 
  XX PPI

Fosamax (alendronate sodium) tablets and oral solution

* Bisphosphonates Class Label Change

  XX MG

Fosamax Plus D (alendronate sodium/cholecalciferol) tablets

* Bisphosphonates Class Label Change

  XX MG
Kayexalate (sodium polystyrene sulfonate) powder   XXX 
Oxytrol (oxybutynin transdermal system)   XX  
Prilosec (omeprazole) Delayed-Release Capsules,  
Prilosec (omeprazole magnesium) For Delayed Release Oral Suspension
  XX  

Reclast (zoledronic acid) Injection

* Bisphosphonates Class Label Change

  XX MG
Rituxan (rituximab)   XX  
Sanctura (trospium chloride) tablets  XX  
Sanctura XR (trospium chloride extended release capsules)  XX  
Tasigna (nilotinib) Capsules  XX  
Tessalon (benzonatate) Perles and Capsules  XXX 

Trelstar (triptorelin palmoate)

Trelstar (triptorelin palmoate) Depot

  XX  
Viagra (sildenafil citrate) Tablets   X X 
Zoladex (goserelin acetate) implant, 3.6 mg
Zoladex (goserelin acetate) implant, 10.8 mg
  XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Eligard (leuprolide acetate) for Injectable Suspension    X  
Famvir (famciclovir) Tablets    X  
Multaq (dronedarone hydrochloride) Tablets    X  

Lupron (leuprolide acetate) Injection

Lupron Depot (leuprolide acetate for depot suspension)  

   X  
Vantas (histrelin acetate) Subcutaneous Implant    X  
Viadur (leuprolide acetate implant)    X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Advicor (niacin extended release/lovastatin) Tablets    X 
Agrylin (anagrelide hydrochloride) Capsules     X 
Astepro (azelastine hydrochloride) Nasal Spray     
X
 
Lotrel (amlodipine besylate/benazapril hydrochloride) Capsules    
X
 
Pristiq (desvenlafaxine) Extended-Release Tablet     
X
 
Synarel (nafarelin acetate) Nasal Solution 2mg/mL     
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder)      MG
Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol     MG
Dilantin (phenytoin)     MG
Viramune (nevirapine) tablets and oral suspension     MG