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U.S. Department of Health and Human Services

Safety

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August 2008

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

Abilify (aripiprazole) Tablets

Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets

Abilify (aripiprazole) Oral Solution

Abilify (aripiprazole) Injection For Intramuscular Use Only

X   X      
Clozaril (clozapine HCl) Tablets
X
 
X
     
FazaClo (clozapine) Orally Disintegrating Tablets
X
 
X
     

Geodon (ziprasidone HCl) Capsules

Geodon (ziprasidone mesylate) for Injection - For IM Use Only

X
 
X
     
Haldol (haloperidol injection) For Immediate Release
X
 
X
     
Haldol Decanoate (haloperidol) For IM Injection Only
X
 
X
     
Invega (paliperidone) Extended-Release Tablets
X
 
X
     
Moban (molindone hydrochloride tablets, USP)
X
 
X
     

Navane (thiothixene capsules)

Navane (thiothixene hydrochloride concentrate)

X
 
X
     

Risperdal (risperidone) Tablets

Risperdal (risperidone) Oral Solution

Risperdal M-Tab (risperidone) Orally Disintegrating Tablets

X
 
X
     
Risperdal Consta (risperidone) Long-Acting Injection
X
 
X
     
Seroquel (quetiapine fumarate) Tablets
X
 
X
     
Seroquel XR (quetiapine fumarate) Extended-Release Tablets
X
 
X
     
Symbyax (olanzapine and fluoxetine HCl capsules)
X
 
X
     
Viread (tenofovir disoproxil fumarate) Tablets
X
X
X
X
X
PPI

Zyprexa (olanzapine tablets)

Zyprexa Zydis (olanzapine orally disintegrating tablets)

Zyprexa IntraMuscular (olanzapine for injection)

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

BW

C

W

P

AR

PPI/MG
Metadate CD (methylphenidate HCl, USP) Extended-Release Capsules  
X
 
X
X
 
Reyataz (atazanavir sulfate) Capsules  

X

 
X
 
PPI
Rocephin (ceftriaxone sodium) For Injection  
X
X
X
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Phosphocol P 32 (chromic phosphate P 32 suspension)    
X
X
X
 
Retisert (fluocinolone acetonide intravitreal implant)    
X
X
X
 
Sustiva (efavirenz) Capsules and Tablets    
X
 
X
 
Vidaza (azacitidine for injection) For SC or IV Use    
X
X
X
 
Zemuron (rocuronium bromide) Injection Solution For Intravenous Use    
X
X
 
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Corzide (nadolol and bendroflumethiazide tablets)      
X
 
 

Glucophage (metformin hydrochloride tablets)

Glucophage XR (metformin hydrochloride extended-release tablets)

      X  
 
Kerlone (betaxolol hydrochloride tablets)      
X
 
 
Metaglip (glipizide and metformin HCl) Tablets      
X
 
 

Norvir (ritonavir capsules) Soft Gelatin

Norvir (ritonavir oral solution)

     
X
 X PPI
Precose (acarbose tablets)      
X
 
 
Sandostatin (octreotide acetate) Injection      
X
 
 
Somavert (pegvisomant for injection)      
X
X PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Cialis (tadalafil) Tablet, Film Coated        
X
 
Estring (estradiol vaginal ring)        
X
PPI
Femara (letrozole tablets)        
X
 
Megace ES (megestrol acetate oral suspension)        
X
 
Symlin (pramlintide acetate) Injection        
X
 
Synagis (palivizumab) For Intramuscular Administration        
X
 
Viagra (sildenafil citrate) Tablets         X  

Zovirax (acyclovir) Capsules and Tablets

Zovirax (acyclovir) Suspension

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

BW

C

W

P

AR

PPI/MG
Omnitrope Pen 10 (somatropin [rDNA origin] injection), For Subcutaneous Use           PPI