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U.S. Department of Health and Human Services

Safety

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April 2010

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

BW

C

W

P

AR

PPI/MG

Aptivus (tipranavir) capsules

*protease inhibitors change

  X        

Crixivan (indinavir sulfate) capsules

*protease inhibitors change

  X   X    

Invirase (saquinavir mesylate) capsules and tablets

*protease inhibitors change

  X   X    

Kaletra (lopinavir/ritonavir) capsules, tablets, and oral solution

*protease inhibitors change

  X   X    

Lexiva (fosamprenavir calcium) tablets and oral suspension

*protease inhibitors change

  X   X    

Prezista (darunavir) tablet

*protease inhibitors change

  X   X    

Reyataz (atazanavir) capsules

*protease inhibitors change

  X   X    

Viracept (nelfinavir mesylate) tablets and oral powder

*protease inhibitors change

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

BW

C

W

P

AR

PPI/MG
Acephen (acetaminophen) rectal suppositories [OTC]     X      
Artiss (Fibrin Sealant)     X X X  
Evicel (Fibrin Sealant)     X X X  
FeverAll (acetaminophen) rectal suppositories [OTC]     X      
Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system     X      
Rapamune (sirolimus) oral solution and tablets     X X X  
Sandimmune (cyclosporine) soft gelatin capsules, injection, and oral solution     X X X  
Tarceva (erlotinib) tablets     X X X  
Tisseel (Fibrin Sealant)     X X X  
Uroxatral (alfuzosin HCl) extended-release tablets     X X    
Valtrex (valacyclovir hydrochloride) caplets     X X    
Ventavis (iloprost) inhalation solution     X X X  
Vytorin (ezetimibe/simvastatin) tablets     X X    
Yasmin (drospirenone 3 mg/ethinyl estradiol 0.03 mg) tablets     X      
Yaz (drospirenone 3 mg/ethinyl estradiol 0.02 mg) tablets     X      
Zocor (simvastatin) tablets     X X    
Zonegran (zonisamide) capsules     X X    
Zyprexa Relprevv (olanzapine) for extended release injectable suspension     X X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Ambien IR and Ambien CR (zolpidem tartrate)tablets       X    

Calan (verapamil hydrichloride) intravenous Injection and Intravenous Injection syringe

 

Calan (verapamil hydrochloride) tablets

      X    

Catapres (clonidine hydrochloride) tablets 

 

Catapres-TTS (clonidine) transdermal therapeutic system

      X    
Covera HS (verapamil hydrochloride) extended release tablets       X    
Flumadine (rimantadine hydrochloride) tablets       X    
Lidoderm (lidocaine 5%) patch       X    
Mavik (trandolapril) tablets       X X  

Norvir (ritonavir) capsules

*protease inhibitors change

      X    

Norvir (ritonavir) tablet for oral use and solution for oral use

*protease inhibitors change

      X    
Ritalin LA (methylphenidate hydrochloride) extended-release capsules       X X  

Verelan (verapamil hydrochloride) capsules

 

Verelan PM (verapamil hydrochloride) extended-release capsules

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

BW

C

W

P

AR

PPI/MG

Allegra-D 12 hour (fexofenadine HCL 60mg/pseudoephedrinie HCL 120mg)

Allegra-D 24 hour (fexofenadine HCL 180mg/pseudoephedrinie HCL 240mg) extended release tablets

       
X
 
Diovan HCT (valsartan/hydrochlorothiazide) tablets        
X
 
Leukeran (chlorambucil) tablets        
X
 
Lupron and Lupron Depot (leuprolide acetate) injection         X  
Ondansetron injection, premix for intravenous use        
X
 
Taxotere (docetaxel) injection concentrate        
X
 
Temodar (temozolomide) capsules and for injection         X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Folotyn (pralatrexate) injection           PPI