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U.S. Department of Health and Human Services

Safety

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July 2013

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
Depakene (valproic acid) Capsules and Oral Solution
Depakote (divalproex sodium) Delayed Release
Depakote ER (Extended Release) Tablets
Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules)
Depacon (valproate sodium) Injection
 
X
XXX  
Nizoral (ketoconazole) Tablets 
X
XX   
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Nucynta (tapentadol) Immediate-Release (IR) Oral Tablets  XXXX 
Prolia (denosumab) XXX  
Rapaflo (silodosin) Capsules X  X 
Sarafem (fluoxetine hydrochloride) Tablets
 
 XXXXMG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Agrylin (anagrelide hydrochloride) Capsules   X X 

Azor (amlodipine/olmesartan medoxomil) Tablets

*Sprue-like Enteropathy 

  X   
Azulfidine EN-Tablets (sulfasalazine delayed release tablets, USP)  XXX 
Bactrim and Bactrim DS Tablets   XXX 

Benicar (olmesartan medoxomil)

*Sprue-like Enteropathy 

  XXX 

Benicar HCT (olmesartan medoxomil/ hydrochlorothiazide) Tablets

*Sprue-like Enteropathy 

  XXX 
Dulera (mometasone furoate/formoterol fumarate) Inhalation Aerosol   XXX 
Elspar (asparaginase)  XXX 
Geodon (ziprasidone) Capsules, Injection and Oral Suspension   XX  
Lupron Depot (Leuprolide Acetate for Depot Suspension)  XXX 
MultiHance (gadobenate dimeglumine) Injection and MultiHance Multipack (gadobenate dimeglumine) Injection   XX  
Pentasa (mesalamine) Controlled-Release Capsules   XX  
Prozac (fluoxetine hydrochloride) Delayed Release Capsules   XX  
Symbyax (olanzapine and fluoxetine hydrochloride) Capsules    XX  

Tribenzor (olmesartan medoxomil/ amlodipine/ hydrochlorothiazide) Tablets

*Sprue-like Enteropathy

  XXX 
Vivitrol (naltrexone for extended-release injectable suspension)   XX  
Zelboraf (vemurafenib) Tablets   XXX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Abilify (aripiprazole) Tablets, Oral Solution, Orally Disintegrating Tablets, and Injectable Formulation    X  
Procardia (nifedipine) Capsules    X  
Procardia XL (nifedipine) Tablets    X  
Tenex (guanfacine hydrochloride) Tablets    X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Caprelsa (vandetanib)     
X
 
Clozaril (clozapine) Oral Tablets    X 
Eloxatin (oxaliplatin) Injection     
X
 
INVANZ (ertapenem) Injection, 1 gm    X 
Keppra (levetiracetam) Tablets, XR tablets, Oral Solution, Injection      X 
Oracea (doxycycline) Capsules     X 
Viread (tenofovir disoproxil fumarate) Oral Powder, 40 mg/gram    X