• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

December 2011

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
*fetal toxicity
 X XX  

Edarbi (azilsartan medoxomil) Tablets 

*fetal toxicity

 X X   PCI/PPI
Multaq (dronedarone hydrochloride) tablets
X
X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
 X  X  X  
Norvir (ritonavir) Soft Gel capsules, tablets, and oral solution XXXXPPI

Relenza (zanamivir) inhalation powder

 X    PPI 
Tyzeka (telbivudine) tablets and oral solution XX X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Danocrine brand of Danazol capsules

  X X X 
Desferal (deferoxamine mesylate) for injection   XX  
Eloxatin (oxaliplatin)  for intravenous use  X X   

Heparin Sodium Injection

  X X   
Isentress (raltegravir) scored, chewable tablets, film coated tablets  X X  
Keppra (levetiracetam) Tablets and oral solution  X X   
Onglyza (saxagliptin) tablets  XXX 

Ovide (malathion) 0.5% lotion

  X  X  

PegIntron (Peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use

  X X   

Plavix (clopidogrel bisulfate) tablets

  X X   
Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine) Orally Disintegrating tablets  X   
Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension and capsules  XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Avapro (irbesartan) Tablets   XX 
Diovan HCT (valsartan/hydrochloriothiazide) Tablets    X PPI
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) tablets   X  
Isoptin SR (verapamil hydrochloride) tablets   X  
   X  

Solaraze (diclofenac sodium) gel 3%

   X  

Sustiva (efavirenz) capsules and tablets

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

BW

C

W

P

AR

PPI/MG

Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable

suspension) (albumin-bound), 100 milligram vial

    
X
 
Avastin (bevacizumab) Solution for intravenous infusion    
X
 

Cleviprex (clevidipine) 0.5 mg/mL injectable emulsion

    
X
 

Elestat (epinastine hydrochloride ophthalmic solution) 0.05%

    
X
 

Femara (letrozole) tablets

    
X
 

Prezista (darunavir) suspension and tablets

    
X
 
Proleukin (aldesleukin)    
X
 

Protonix (pantoprazole sodium) for injection

    
X
 
Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules    
X
PPI
Toviaz (fesoterodine fumarate) extended release tablets    
X
 
Vancocin  (vancomycin hydrochloride) Capsules    
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
     PCI
Diovan (valsartan) Tablets     PPI
Vytorin (ezetimibe/simvastatin) Tablets     PPI