Safety

September 2015

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
Brilinta (ticagrelor) Tablets
X
  X      
Clozaril (clozapine) Tablets X X X X X  
Combivir (lamivudine and zidovudine) Tablets X   X X X PCI
Epzicom (abacavir and lamivudine) Tablets
X
  X X X  
Fazaclo (clozapine) Orally Disintegrating Tablets
X
X   X    
Triumeq (abacavir sulfate, dolutegravir, and lamivudine) Tablets X X X X    
Trizivir (abacavir, lamivudine, and zidovudine) Tablets X X X X X PCI, MG
Versacloz (clozapine) Oral Suspension X X X X    
Ziagen (abacavir) Tablets and Oral Solution X X X X X PCI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Cialis (tadalafil) Tablets

*PDE5 Inhibitors - Increased Risk of Hypotension with Concomitant Use of Guanylate Cyclase Stimulators

  X       PCI

Levitra (vardenafil hydrochloride) Tablets

*PDE5 Inhibitors - Increased Risk of Hypotension with Concomitant Use of Guanylate Cyclase Stimulators

  X       PCI
Myalept (metreleptin) for Injection   X X X    

Staxyn (vardenafil hydrochloride) Orally Disintegrating Tablets

*PDE5 Inhibitors - Increased Risk of Hypotension with Concomitant Use of Guanylate Cyclase Stimulators

  X       PCI

Stendra (avanafil) Tablets

*PDE5 Inhibitors - Increased Risk of Hypotension with Concomitant Use of Guanylate Cyclase Stimulators

  X       PCI

Viagra (sildenafil citrate) Tablets

*PDE5 Inhibitors - Increased Risk of Hypotension with Concomitant Use of Guanylate Cyclase Stimulators

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

BW

C

W

P

AR

PPI/MG
Altace (ramipril) Capsules      X X    
Bydureon (exenatide extended-release) for Injectable Suspension     X X    
Doryx (doxycycline hyclate) Delayed-Release Capsules     X X X  
Gazyva (obinutuzumab)     X X    
Humira (adalimumab) Solution     X X    
Invokamet (canagliflozin and metformin HCl) Tablets     X X X  
Invokana (canagliflozin) Tablets     X X X  
Neulasta (pegfilgrastim) Prefilled Syringe/On-body Injector     X X    
Neurontin (gabapentin) Capsules, Tablets, and Syrup     X X X PCI
Proglycem (diazoxide) Capsules and Oral Suspension     X   X  
Sabril (vigabatrin) Tablet and Powder for Oral Solution     X X    
Sancuso (granisetron)     X   X  
Votrient (pazopanib) Tablets     X X X PCI
Xalkori (crizotinib)     X X X  
Zestril (lisinopril) Tablets     X X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Accupril (quinapril hydrochloride) Tablets       X    
Accuretic (quinapril hydrochloride/hydrochlorothiazide) Tablets       X    
Avastin (bevacizumab)       X X  
Nicorette (nicotine polacrilex) Gum
Nicorette (nicotine polacrilex) Large Lozenge
      X    
PegIntron (peginterferon alfa-2b) Injection, for Subcutaneous Use        X    
Velcade (bortezomib) for Injection       X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Breo Ellipta (fluticasone furoate/vilanterol) Inhalation Powder        
X
 
Cubicin (daptomycin for injection)         X  
Depakene (valproic acid) Capsules
Depakene (valproic acid) Oral Solution
Depakote (divalproex sodium) Delayed Release Tablets
Depakote Sprinkle Capsules (divalproex sodium delayed release capsules)
Depacon (valproate sodium) Injection
Depakote ER (divalproex sodium) Extended Release Tablets
        X  
Eliquis (apixaban) Tablets        
X
 
Estring (estradiol vaginal ring)         X  
Intermezzo (zolpidem tartrate) Sublingual Tablets         X  
Lastacaft (alcaftadine ophthalmic solution)         X  
Pradaxa (dabigatran etexilate mesylate) Capsules         X  
Savaysa (edoxaban tosylate) Tablets        
X
 
Temodar (temozolomide) Injection for Intravenous Use         X  
Xarelto (rivaroxaban) Tablets         X  
Zioptan (tafluprost ophthalmic solution)         X  
 
 
     

 

Page Last Updated: 10/09/2015
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