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U.S. Department of Health and Human Services

Safety

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February 2012

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 XPCI
Benicar (olmesartan medoxomil) TabletsX X  
X X  
Letairis (ambrisentan) Tablets
X
 X PPI/MG 
*Fetal Toxicity
X
  PCI 

Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets

*Fetal Toxicity

X X X X PPI/MG 
*Fetal Toxicity
X
  PCI 
*Fetal Toxicity
X
   
*Fetal Toxicity
X
 XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
 X X  X   
Crixivan (indinavir sulfate) Capsules X X  X  PPI/MG
 X X  X   
 X X  X  
Phendimetrazine tartrate SR 105 mg capsules X X 
 XXXPPI/MG
 XXXPPI/MG
Simcor (niacin ER/simvastatin) Tablets  X X  X  PPI/MG 
Viracept (nelfinavir mesylate) Oral Powder X X  X   PPI/MG 
 X X X  
 XXX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
  X X    
Aptivus (tipranavir) Capsules and Oral Solution  X X   PPI/MG 
  X X  X  
*VTE risk
  X X   
Crestor (rosuvastatin calcium) Tablets  X X XPPI/MG 
Diovan HCT (valsartan/hydrochlorothiazide) Tablets  X X X 
PCE (erythromycin particles in tablets) 333 mg and 500 mg film coated tablets  X   
  X X PPI
  X X  
Hepsera (adefovir dipivoxil) tablets  XX PPI/MG 
  XX PPI/MG
  X X  PPI/MG

Lescol (fluvastatin sodium) Capsules,

Lescol XL (fluvastatin sodium) Extended-Release Tablets

  XX 
Lexiva (fosamprenavir calcium) tablets and oral suspension  X X  PCI 
Lipitor (atorvastatin calcium) Tablets  X X PPI/MG
  X X  
  X X  X PCI 
Natazia (estradiol valerate and estradiol valerate/dienogest) tablets  X X   
  XX PCI
  XX  
  X X X 
  X X XPPI/MG
  X X XPPI/MG
  X X  PPI/MG
Reyataz (atazanavir sulfate) Capsules  X X   
  X X  X MG 
*VTE risk
  X X   
  X X  PPI/MG
Yasmin (drospirenone/ethinyl estradiol) tablets  X X  PPI/MG
Zyvox (linezoid) Tablets, Oral Suspension  X   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Diovan (valsartan) Tablets            XX 
Kaletra (lopinavir/ritonavir) Capsules   X PPI/MG
Norvir (ritonavir) Capsules   X PPI/MG 
Samsca (tolvaptan) tablets   X  
Tykerb (lapatinib) Tablets    X  
   X  
   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Adderall XR (dextroamphetamine mixed salts of a single-entity amphetamine product) Capsules    
X
 
    
X
 
    
X
 
Precose (acarbose) Tablets    
X
 
Prograf (tacrolimus) capsules and injection    
X
 
Sodium Iodide I-131 Therapeutic Capsules and Therapeutic Solution    
X
 
    
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
     PPI/MG