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U.S. Department of Health and Human Services

Safety

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October 2010

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

Altace (ramipril) capsules

X  X X  
Letairis (ambrisentan) tablets
X
XXX X MG 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Invirase (saquinavir mesylate) tablets

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

BW

C

W

P

AR

PPI/MG
Aldara (imiquimod) cream  XX  

Depo-Provera Contraceptive injection (medroxyprogesterone acetate) injectable suspension

  XX  

Enablex (darifenacin) extended-release tablets

  XXXPPI
Fragmin (dalteparin sodium) injection  X X   

Gris-PEG (griseofulvin ultramicrosized) tablets

  X X 

Ibuprofen [OTC]

Children’s Motrin oral suspension, 100 mg/5 mL

Junior Strength Motrin (ibuprofen) tablets, 100 mg

Motrin IB tablets

Motrin Junior Strength chewable tablets, 100 mg

*organ specific warnings

  X   

Lamictal (lamotrigine) tablets, chewable dispersible tablets, Lamictal ODT (lamotrigine) orally disintegrating tablets, and Lamictal XR (lamotrigine) extended-release tablets

  X X   PCI 

Lasix (furosemide) tablets

  X X X 

Myfortic(mycophenolic acid) delayed-release tablet

  XX  

Nexavar (sorafenib tosylate) tablets

  X X  X  

Nuvigil (armodafinil) tablets

  X   

Precedex (dexmedetomidine hydrochloride) injection

  XXX 

Procardia XL (nifedipine) extended release tablets

  X X X 
Provigil (modafinil) tablets  X   

Rebetol (ribavirin) capsules and oral solution

 
 XX  

Rythmol SR (propafenone hydrochloride) extended-release capsules

 
 XXX 

Sprycel (dasatinib) tablets

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

BW

C

W

P

AR

PPI/MG

Comtan(entacapone) tablets

   X  

Combivir (lamivudine/zidovudine) tablets

   X  
Cyanokit (hydroxocobalamin) intravenous use   X  
Eligard (leuprolide acetate) for injectable suspension   X  
Finacea (azelaic acid) gel   X  

Paxil (paroxetine HCl) tablets, oral solution and Paxil CR tablets

   XX 

Stalevo (levodopa/carbidopa/entacapone) tablets

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

BW

C

W

P

AR

PPI/MG
Cancidas (caspofungin acetate) for Injection    
X
 

Copegus (ribavirin) tablets

    
X
 

Lupron Depot and Lupron Depot 3 month (leuprolide acetate) for depot suspension

    
X
 
Proscar (finasteride) tablets    
X
PPI

Viread (tenofovir disoproxil fumarate) tablets

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

BW

C

W

P

AR

PPI/MG

Accolate (zafirlukast) tablets

     PPI
Pristiq (desvenlafaxine) extended-release tablets      MG