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U.S. Department of Health and Human Services

Safety

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December 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

Ablavar (gadofosveset trisodium) injection

*nephrogenic systemic fibrosis

X XX PCI

Aceon (perindopril erbumine) tablets

 X X  X 
Eovist (Gadoxetate disodium) injection

*nephrogenic systemic fibrosis (NSF)

X
 XX PCI

Magnevist (gadopentetate dimeglumine) injection and pharmacy bulk package injection

*nephrogenic systemic fibrosis (NSF)

X
XXX PCI

MultiHance (gadobenate dimeglumine) injection

*nephrogenic systemic fibrosis (NSF)

X
 XX PCI

Omniscan (gadodiamide) injection and pharmacy bulk package injection

*nephrogenic systemic fibrosis

 X  XX X   PCI 

Optimark (gadoversetamide) injection and pharmacy bulk package injection

*nephrogenic systemic fibrosis

 X  XX   

Prohance (gadoteridol) injection and multipack injection

*nephrogenic systemic fibrosis

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

BW

C

W

P

AR

PPI/MG

Copegus (ribavirin) tablets

 XXX  

Terconazole Vaginal Cream

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

BW

C

W

P

AR

PPI/MG

Baraclude (entecavir) tablets and oral solution

  X X X 

Innopran XL (propranolol hydrochloride) capsules

  XX X  

Prilosec OTC (omeprazole magnesium) delayed-release tablets

  X   

Pristiq (desvenlafaxine) extended-release tablets

  XX  

Relenza (zanamivir) inhalation powder

  X X X 
Remicade (inflximab ) for Intravenous (IV) injection
 
  X X 

Zegerid OTC capsules

  X   

Zerit (stavudine) capsules and oral solution

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

BW

C

W

P

AR

PPI/MG

Abilify (aripiprazole) tablet, oral solution, orally disintegrating tablet, and injectable formulation

*extrapyramidal and/or withdrawal symptoms

   X  
Arthrotec (diclofenac sodium/misoprostol) oral tablets   X  

Campral (acamprosate calcium) delayed-release tablets

   X  
Carafate (sucralfate) suspension   X X  

Clinoril (sulindac) tablets

   X  

Clozaril (clozapine) tablets

*extrapyramidal and/or withdrawal symptoms

   X  
Dermatop (prednicarbate cream) Cream and Dermatop (prednicarbate ointment) ointment   X  

Fanapt (iloperidone) tablets

*extrapyramidal and/or withdrawal symptoms

   X  

Fazaclo (clozapine) orally disintegrating tablets

*extrapyramidal and/or withdrawal symptoms

   X  

Geodon (ziprasidone HCl) capsules, oral suspension and Geodon (ziprasidone mesylate) injection

*extrapyramidal and/or withdrawal symptoms

   X  

Haldol (haloperidol) injection and Haldol Decanoate IM injection

*extrapyramidal and/or withdrawal symptoms

   X  

Inomax (nitric oxide) inhalation

   X  

Invega (paliperidone) extended-release tablets

*extrapyramidal and/or withdrawal symptoms

   X  

Invega Sustenna (paliperidone) intramuscular injection

*extrapyramidal and/or withdrawal symptoms

   X  

Ketek (telithromycin) tablets

   X  

Moban (molindone HCL) tablets

*extrapyramidal and/or withdrawal symptoms

   X  

Navane (thiothixene) capsules

*extrapyramidal and/or withdrawal symptoms

   X  

Orap (pimozide) tablets

*extrapyramidal and/or withdrawal symptoms

   X  

Riomet (metformin HCl) oral solution

   X  

Risperidone tablets, rapidly disintegrating tablets, solution, and longacting injection

*extrapyramidal and/or withdrawal symptoms

   X  

Saphris (asenapine) sublingual tablets

*extrapyramidal and/or withdrawal symptoms

   X  

Serevent Diskus (salmeterol xinafoate) inhalation powder

   X  

Seroquel (quetiapine fumarate) tablets and Seroquel XR (quetiapine fumarate) extended release tablets

*extrapyramidal and/or withdrawal symptoms

   X  

Symbyax (olanzapine and fluoxetine HCL) capsules

*extrapyramidal and/or withdrawal symptoms

   X  

Tamiflu (oseltamivir phosphate) capsules and oral suspension

   X  

Uroxatral (alfuzosin HCL) extended-release tablets

   X  

Zyprexa (olanzapine) tablets

*extrapyramidal and/or withdrawal symptoms

   X  

Zyprexa Zydis orally disintegrating tablets and IM injection

*extrapyramidal and/or withdrawal symptoms

   X  

Zyprexa Relprevv (olanzapine) for extended release injectable suspension

*extrapyramidal and/or withdrawal symptoms

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

BW

C

W

P

AR

PPI/MG

Chantix (varenicline) tablets

    
X
 
Cordarone (amiodarone HCl) tablets    
X
 

Cubicin (daptomycin) for injection

    
X
 
Intelence (etravirine) tablet    
X
PCI

Timentin (sterile ticarcillin disodium and clavulanate potassium) for intravenous administration

    
X
 

Treanda (bendamustine hydrochloride) lyophilized solid for injection

    
X
 

Velcade (bortezomib) for injection

     X  

Victoza (liraglutide [rDNA origin]) injection

    
X
 

Vytorin (ezetimibe/simvastatin) tablets

    X PPI 

Xolegel (ketoconazole) topical gel

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

BW

C

W

P

AR

PPI/MG

Prezista (darunavir) tablets

      PCI