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U.S. Department of Health and Human Services

Safety

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July 2009

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
Chantix (varenicline) 0.5 mg and 1 mg tablets X   X X X X
Wellbutrin (bupropion hydrochloride) tablets, Sustained-Release, and Extended Release (XL) tablets  X   X X   MG
Zyban (bupropion hydrochloride) Sustained-Release tablets
X
  X X   MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Diabeta (glyburide) tablets   X X X X  
Lopid (gemfibrozil) tablets   X   X    
Ortho Evra (norelgestromin / ethinyl estradiol) transdermal system   X X   X  
Veramyst (fluticasone furoate) nasal spray   X X X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Actonel (risedronate sodium) tablets     X X    
Gardasil (Human Papillomavirus Quadrivalent Types 6, 11, 16, 18) Recombinant Vaccine     X X    
Letairis (ambrisentan) 5 and 10 mg tablets     X X   MG
Myfortic (mycophenolic acid) 180 mg and 360 mg delayed-release tablet     X   X MG
Rilutek (riluzole) tablets     X X X  
Soliris (eculizumab)     X X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Abilify 

 

Abilify (aripiprazole) 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets

Abilify (aripiprazole) 1 mg /mL Oral Solution

Abilify Discmelt (aripiprazole)  10 mg and 15 mg Orally Disintegrating Tablets

Abilify (aripiprazole) 9.75 mg / 1.3 mL (7.5 mg /mL) Injection

*labeling for the entire class of antipsychotic drugs

      X    
Agrylin (anagrelide hydrochloride) 0.5 mg capsules       X    
Calan (verapamil hydrochloride) tablets       X    
Cardura (doxazosin mesylate) 1, 2, 4, and 8 mg tablets       X    

Geodon (ziprasidone) 20 mg, 40 mg, 60 mg, and 80 mg capsules and 20 mg base /mL injection

*labeling for the entire class of antipsychotic drugs

      X    

Haldol (haloperidol) 5 mg base /mL injection and Haldol Decanoate (haloperidol) 50 mg base /mL and 100 mg base /mL IM injection

*labeling for the entire class of antipsychotic drugs

      X    
Hytrin (terazosin hydrochloride) 1, 2, 5, and 10 mg tablets       X    

Invega (paliperidone) 1.5 mg, 3 mg, 6 mg, and 9 mg Extended-Release tablets

*labeling for the entire class of antipsychotic drugs

      X    
Isoptin SR (verapamil HCL) 120 mg, 180 mg, and 240 mg Sustained Release tablets       X    
Minipress (prazosin hydrochloride) 1, 2, and 5 mg capsules       X    

Moban (molindone) 5 mg, 10 mg, 25 mg, and 50 mg tablets

*labeling for the entire class of antipsychotic drugs

      X    

Navane 

 

Navane (thiothixene) 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg capsules

Navane (thiothixene) 5mg base /mL  oral concentrate

Navane (thiothixene) 2 mg base/mL and 10 mg base/mL injectable

*labeling for the entire class of antipsychotic drugs

      X    

Orap (pimozide) 1 mg and 2 mg tablets

*labeling for the entire class of antipsychotic drugs

      X    
Pamidronate disodium injection       X X  
Phisohex (hexachlorophene 3%) detergent cleanser       X    

Risperdal 

 

Risperdal (risperidone) 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg tablets

Risperdal (risperidone) 1 mg / mL oral solution 

Risperdal CONSTA (risperidone) 12.5 mg / vial, 25 mg / vial, 37.5 mg / vial, and 50 mg / vial Long-Acting injection 

Risperdal M-TAB (risperidone) 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg Orally Disintegrating tablets

*labeling for the entire class of antipsychotic drugs

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

BW

C

W

P

AR

PPI/MG
Alimta (pemetrexed disodium) Injection, Powder, Lyophilized for Intravenous Use 100 mg and 500 mg vial          X  
Caduet (amlodipine besylate/atorvastatin calcium) tablets        
X
 
Ditropan (oxybutynin chloride )tablets        
X
 
Ditropan XL (oxybutynin chloride, USP) Extended Release tablets        
X
 
Femara (letrozole) 2.5 mg tablets        
X
 
Isentress (raltegravir potassium) tablets        
X
 
Lovenox (enoxaparin sodium) injection        
X
 
Zetia (ezetimibe) tablets        
X
PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Baraclude (entecavir) tablets and oral solution           PPI